The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 
  

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims.

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our culture and each other. The meeting, including a plenary session, interactive workshops and team-building exercises, was considered to be a great success and further strengthened the superb Mapi Values global team spirit!

The Cancer-Related Fatigue Measurement Consortium
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF).  The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care.  This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA.  The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative. 

Combining Direct and Indirect Comparisons To Provide Value Arguments
Mapi Values has recently run a market access workshop for a number of our key clients. These workshops addressed the use of mixed treatment comparison (MTC) as an extension to traditional meta-analysis. The use of evidence synthesis methods such as MTC as a basis for cost-effectiveness decision-making and to provide value arguments based on clinical or patient-reported outcomes was explained. An overview of MTC methods illustrated with analyses of continuous clinical and patient-reported outcomes was also presented, together with a comparison of the output of MTC with traditional meta-analysis to show that MTC can provide more interesting value messages to support product uptake. Finally, the acceptance of results obtained with MTC by key target audiences was discussed.

Forthcoming publication on PROs to support medical product labeling claims
In July 2007 a special issue of Value in Health will include an article by authors currently and formerly at FDA, including Jane Scott of Mapi Values. This article summarizes the Agency’s current thinking after reviewing feedback to the draft PRO guidance published in February 2006.  This confirms that the FDA expects a number of points that Mapi Values has routinely incorporated in projects with an objective of an FDA-approved PRO claim:

• Link all intended PRO claims to PRO conceptual frameworks, PRO instruments and endpoint models.
• Focus on state-of-the-art rigorous qualitative patient research.
• Clearly document the choice, development and validation of PROs to be used in clinical trials to support claims. 

The Mapi Values Global Team Congress
Mapi Values recently held its second global team congress in Marrakech, Morocco. Under the theme “Together” close to 80 team members from the four offices of Mapi Values met to improve their understanding of our company, our clients, our cult