Patient-Focused Drug Development Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments; Public Workshop; Request for Comments

The Food and Drug Administration (FDA) is announcing a 2-day public workshop to convene a discussion on methodological approaches that may be used to identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease, and best practices for selecting, developing, or modifying fit-for-purpose clinical outcome assessments (COAs) to measure the patient experience in clinical trials. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA will publish discussion documents approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion documents. FDA is also interested in input on examples, which could be illustrated in the draft guidance, where the approaches proposed in the discussion document have been successfully applied.