Is the FDA Making the Right Moves on Clinical Trials?

Recently, the FDA announced new provisions that require sponsors to submit Diversity Action Plans. But what does that mean for the average person? “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”  But the new FDA provisions only require diversity action plans for phase 3 clinical studies. As a 13-year survivor of triple-negative breast cancer and passionate breast cancer advocate, I applaud the FDA’s response to the critical need for diversity in clinical trials. However, this current guidance falls short of making a substantial impact and is only a preliminary step towards what truly needs to be done.    What is a Phase 3 clinical trial? According to FDA.gov, this is the current process for drug development: Phase 1 Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Approximately 70% of drugs move to the next...