A New Consortium in IBS and the Critical Path Institute
Mapi Values is fully supportive of the aims of C-Path’s PRO Consortium*, and is working on ways to share our existing experience with leading a PRO consortium and how it might benefit this important initiative. We have identified the proposed working group in IBS as one potential area for collaboration. The FDA has highlighted the lack of documentation concerning the content validity of PRO endpoints in IBS in a number of reviews. As a result, many clinical programs have been delayed or are on hold. In order to speed the resolution of this situation, Mapi Values has undertaken research activities, including focus groups with IBS patients. This state-of-the-art qualitative research documents the patients’ experience of IBS symptoms and their impact in an unbiased way. We will make the data available to the PRO Consortium IBS working group when this is launched by C-Path.Meanwhile, the data may be used by our sponsors to support the content validity of the PRO endpoint in their NDA submission in any upcoming or ongoing discussions with the FDA.The data include:
A comprehensive literature review and critical evaluation of existing PRO instruments in IBS;
The results of the focus groups (four in IBS-C and four in IBS-D), conducted using the FDA standards for endpoint development and documentation;
Preliminary conceptual frameworks with documented evidence of saturation with regard to concepts for patient-reported symptom severity for IBS-C and IBS-D.
This strategy enables sponsors to establish a symptom assessment with documented content validity as quickly as possible, while satisfying the FDA agenda to work collaboratively on the development of PRO endpoints in IBS. If you want more information on the project or a presentation of the data, please contact Chris Evans byemailor phone: (+1) 617 720 0001.
* The Critical Path Institute (C-Path) is an independent, non-profit organization dedicated to implementing the FDA's Critical Path Initiative. C-Path's mission is to enable innovative collaborations between regulators, academics and the industry, to make the process of developing medical products faster, safer and smarter. C-Path has identified the development and evaluation of PRO instruments for regulatory medical decision-making and to support labeling claims as an area that would benefit from a collaborative approach.
Mapi Values gains insight on the Asian market through its office in Tokyo Mapi Values officially opened its Asian office in the Fall of 2007 in order to meet increased demand for market access and PRO services in Japan, Korea, China, Thailand, Taiwan and other countries. Since establishing a presence in Asia, Mapi Values has conducted burden of disease, cohort, medical record database and psychometric validation studies in Japan; modeling work, HTA review and workshops in Korea; PRO assessments in China and training with the Thai FDA and Japanese PMDA. Meetings with regulators and reimbursement decision makers have allowed Mapi Values to implement studies in a pragmatic and scientific manner.
During the recent ISPOR meeting in Seoul, Mapi Values’ General Manager for Asia, Bruce Crawford, ran a short course in conjunction with Watcharee Leurmankul from Family Health International Thailand, on Quality of Life Assessment and Patient-Reported Outcomes. In addition, two well-received workshop presentations were given to attendees: (1) Meta-analysis Methods that Allow for the Comparison of Interventions in the Absence of Head-to-Head Data and (2) Expert Opinion and Country Specific Model Adaptations. Mapi Values also had two posters looking at item response theory and cultural differences in the transferability of PRO data.
For more information, contact Bruce Crawford, MA, MPH in our Asian office.
Mapi Values expands its Market Access offering in the USA In order to better serve our US clients, we are proud to announce we have expanded our global Market Access team with US-based researchers and consultants. Together with their colleagues in the UK and the Netherlands, the US Market Access team is at the forefront of developments in methodology and policy, applying cutting-edge outcomes research techniques for Health Technology Assessment. We offer a range of services with a specific focus on Evidence synthesis, Indirect/mixed treatment comparisons and Comparative effectiveness.
Our Market Access team comprises a total of more than 35 researchers and senior consultants with multi-disciplinary experience in industry, consultancy, regulatory affairs, and academia. As a global company, Mapi Values has an integrated team culture, fostering efficient international project management and delivery. Our approach ensures that we are able to effectively generate, interpret, and communicate Clinical, PRO and Health Economic evidence in order to optimize local market access for your product.
For more information, contact Jeroen Jansen, PhD in the Boston office or Anne Heyes, MBA in the UK office.
A New Consortium in IBS and the Critical Path Institute
Supportive of the aims of C-Path’s PRO Consortium, we are working to share our existing experience with a PRO consortium by applying it to a new consortium in IBS... READ MORE
Mapi Values gains insight on the Asian market through its office in Tokyo
Mapi Values officially opened its Asian office in the Fall of 2007 in order to meet increased demand for market access and PRO services...READ MORE
Mapi Values expands its Market Access offering in the USA
In order to better serve our US clients, we are proud to announce we have expanded our global Market Access team...READ MORE
Mapi Values prides itself in offering its clients only the very best in outcomes research. To this end, the quality of our work and the level of service we deliver to clients is of paramount importance to us.
Already established as the global leader in the international development of Patient-Reported Outcomes (PROs), Mapi Values is also a leading provider of Health Technology Assessment and Value Demonstration, offering strategic advice and services across all phases of a product’s lifecycle. Our approach ensures that we are able to effectively develop and interpret Health Economic and PRO arguments in order to optimize market access and appropriate medical intervention.
With the ongoing addition to the team of senior members with extensive industry experience and numerous eminent experts in their chosen fields, Mapi Values can justifiably claim to offer one of the world’s finest internal task forces. Through our continued involvement with the FDA and the EMEA on Patient-Reported Outcomes, we offer vast experience in regulatory submissions. With our industry-respected health economic academic and policy experts complementing the team we are also well placed to offer compelling outcomes arguments to help maximize labeling, optimum pricing, reimbursement and product uptake worldwide.
With our head office in Boston, Massachusetts and further operations in the UK, France, the Netherlands, and Japan we offer both global and localized services with the application of state-of-the-art methods. No matter what the project, whenever we begin work on a client’s behalf we do so with that end result firmly in mind.
