Patient-Focused Drug Development (PFDD)
Patient Focused Medicines Development (PFMD)
Based on the 21st Century Cures Act in June 2017 the US FDA issued guidance to help us better engage with patients, caregivers, and families to produce improved outcomes. In the EU, the European Medicines Agency (EMA) has issued similar guidance – Patient Focused Medicines Development – PFMD. There are parallel activities of which you should be aware.
For years, we at IHS have been touting the value of getting patient insights early to inform building protocols with endpoints meaningful to patients and families, not just researchers. Now, the FDA is asking that you do just that. Additional resources: Inspired Health Strategies case study exemplifying the value of early patient/caregiver input
Search for a clinical trial relevant to you: https://www.clinicaltrials.gov