Perform Patient Preference Studies

Overview

Capturing data on how patients perceive potential risks and benefits of new treatments can inform therapy development and the U.S. Food and Drug Administration (FDA) marketing review process. Patient preference studies, also known as patient-centered benefit-risk studies, can help identify what is most important to patients, particularly when assessing benefits and risks are challenging.

Resources

Engage with the FDA

FDA Patient Affairs U. S. Food and Drug Administration (FDA) (link)

FDA For Patients Website U. S. Food and Drug Administration (FDA) (link)

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)

Benefit-Risk Boot Camp FasterCures (link)