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The Mapi Values team provides statistical consultancy related to both Patient-Reported Outcomes (PROs) and our work in Market Access. Our statisticians and psychometricians are experienced in conducting analyses to demonstrate the value of an intervention to payors, patients and health care providers. Our team is focused on treating PROs as unique endpoints in clinical trials requiring specific analyses beyond that required for other endpoints. The goal of our analysis work is to provide our clients with the opportunity to make promotional and labeling claims around PROs in the US, Europe and Asia.
Our statistical services, which follow standard operating procedures (SOPs), are concentrated in the following areas:
- Validation of existing and new PRO questionnaires
- Validation of electronic modes of administration of PRO questionnaires
- Analysis of PRO data included in clinical trials
- Calculation of minimally important clinical difference for PRO measures
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- Imputation methods for missing data
- Structural equation modeling
- Item response theory
- Cumulative response distribution
- Interpretation of PRO data
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Our statisticians and psychometricans work closely with other study team members to ensure that the analysis is aligned to our clients' goals: the demonstration of a products value from the patient's perspective.
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