Tools to Support Sponsor-Patient Engagement: Fair-Market-Value Calculator and Engagement Templates
The NHC wants to ensure that all stakeholders confidently enter into ongoing, compliant, and sustainable engagement efforts that effectively drive health care innovation based on patient and caregiver insights, which must be collected in a trusted and high-quality manner. This project aims to support sustainable agreements between stakeholders and the patient and caregiver community as part of medical product development by:
- Developing, for U.S. use initially (adding other countries in the future), a fair-market value (FMV) calculator for compensation of patients and patient groups involved in “patient engagement activities” taking place between patient organizations and/or unaffiliated patients and private companies. The final product will be a calculator that companies can use and further customize for their own needs. Also, building blocks, such as engagement activities and principles, will be included.
- Adapting, for use in the U.S., the Conflict-of-Interest Principles and Privacy Principles (with examples) developed by the E.U. Patient Focused Medicines Development (PFMD) initiative to create standardization across all activities.
- Adapting, for use in the U.S., the contract templates developed by PFMD to simplify and standardize the process for patient and patient groups.
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