Perform Patient Preference Studies
Tips for Success
- Know what decisions you want to influence and whether the questions you are asking will help you reach that goal.
- Explore whether there are other ways that are less demanding on time and resources to achieve your goals, such as focus groups or interviews.
- Develop collaborations with a shared understanding of the purpose and use of information generated.
- Understand the significance of using sound science to develop and analyze patient preference studies.
- A clear understanding of objectives translates into choosing the appropriate methodologies to achieve those objectives.
- Engage the FDA throughout the process.
- Remember patient and caregiver preferences may change over time as new therapies become available.
- Read Key Considerations in Developing & Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study (2016), a report providing information to help you decide if and when your group wants to conduct a patient preference study. The report also provides more details about the different types of studies and analyses.
- Review Benefit Risk Bootcamp (2014), an overview of sessions from an FasterCures event that describes effective participation in benefit-risk assessment. Descriptions and slide presentations from each session are available. Topics discussed include understanding benefit-risk assessment, common methods used, and key FDA programs.
Engage with the FDA
Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project Report Medical Device Innovation Consortium (MDIC) (link)
FDA-led Patient-Focused Drug Development (PFDD) Public Meetings U. S. Food and Drug Administration (FDA) (link)
Enhancing Benefit-Risk Assessment in Regulatory Decision-Making U. S. Food and Drug Administration (FDA) (link)
Tips for Success
Key Considerations in Developing & Integrating Patient Perspectives in Drug Development: Examination of the Duchenne Case Study Biotechnology Innovation Organization (BIO) and Parent Project Muscular Dystrophy (PPMD) (link)