Drug Trials Snapshots, with John J. Whyte, M.D., MPH, Director, Professional Affairs and Stakeholder Engagement, CDER, FDA

The FDA relies upon mandated, industry-sponsored clinical trials to make decisions about medical products. In years past, questions about adequate and equal inclusion of women and people in racial minority groups have been raised. Many stakeholder groups want FDA to require drug companies to include certain percentages of demographic subgroups in clinical trials and analyze subgroup data by sex, race and age before a drug is approved. While the FDA has many regulations and policies in place regarding clinical trials, these studies are the responsibility of the manufacturer that is developing the drug. To address stakeholder concerns, FDA released an “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” One priority stated in the report is to make demographic data from clinical trials more available and transparent. To reach this goal, FDA’s Center for Drug Evaluation and Research is releasing drug trials snapshots that outline the participation of people in clinical trials by sex, race and age. The drug trial snapshots highlight information in an easy-to-read format.
http://www.fda.gov/Drugs/NewsEvents/ucm424178.htm?source=govdelivery&utm_medium=...