Putting Patients in the Driver’s Seat: How the FDA’s Latest Guidance is Changing the Game for Clinical Trials
1. What’s this all about? The U.S. Food & Drug Administration (FDA) has released a new guidance titled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments”. U.S. Food and Drug AdministrationHere’s the gist: 2. Why this matters In the past, many clinical trials were designed and measured mainly from a “clinician/regulator” perspective. […]