Perform Patient Preference Studies

Engage with the FDA

Groups that have successfully traveled the therapy development path advise engaging with the FDA early in the process of developing and conducting patient preference studies. Establishing an ongoing conversation with the FDA can make certain you are asking your disease community the questions that are significant to the FDA throughout the clinical trial and marketing review process. 

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)
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)