About FDA

FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots

In years past, questions have been raised about the adequate and equal inclusion of women and people from racial, ethnic and other minority groups in the clinical studies that test new medical products. The FDA has been working since the 1980s to increase participation of perse subgroups in clinical trials, and in August 2014, the agency released its Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.

This plan outlines the agency’s recommendations to increase the quality of demographic subgroup data, encourage the participation of a greater persity of subjects in clinical trials, and increase the availability and transparency of demographic subgroup data. In November 2014, FDA’s Center for Drug Evaluation and Research (CDER) launched the Drug Trials Snapshots initiative as a first step to help make clinical trial data more available and transparent. The snapshots will cover all new molecular entity (NME) and original biologic drugs approved beginning in January 2015.

On Monday, April 27, 2015, Dr. John Whyte, Director of CDER’s Professional Affairs and Stakeholder Engagement (PASE) staff described how the Drug Trials Snapshots provide consumers and other stakeholders with information about who participated in the clinical trials that supported FDA approval of new drugs. Dr. Whyte also discussed how the snapshots help consumers to understand any differences in the benefits or side effects among sex, race and age groups.

Presenter: Dr. John Whyte

Download Presentation Slides: Drug Trials Snapshots (PDF - 553KB)

View Webinar: https://collaboration.fda.gov/p7ky0s6t6a1/

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