Perform Patient Preference Studies


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.


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)
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)