FDA Announces Plan To Collect, Share Clinical Trial Data On Demographic Subgroups

The Food and Drug Administration (FDA) has announced a plan to enhance the collection and availability of clinical trial data for demographic subgroups. Margaret A. Hamburg, M.D., Commissioner of the FDA, wrote in the FDA Voice that the 2012 FDA Safety and Innovation Act directed the agency to look at safety and effectiveness data by sex, race/ethnicity, or age. She said the agency complied and reported its findings on August 20, 2013.

Generally, she said, drug sponsors are reporting demographic profiles of trial participants due to the FDA’s “solid framework for providing data.” She also said that the FDA is sharing that information with the public in a variety of ways. However, in accordance with the Safety and Innovation Act, the FDA is producing an action plan to improve the basic framework. She wrote that the agency has three overarching priorities and 27 action items. 

FDA Action Plan

After extensive interaction with stakeholders, the FDA has published the plan titled, “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.” The plan includes efforts to improve the quality and completeness of demographic subgroup data collection, report and analyze data with more quality control, and identify barriers to subgroup enrollment in clinical trials. The federal agency also seeks to identify strategies to enroll more subgroups and share data in a more transparent way.

The steps in the action plan are expected to take from one to five years to achieve. Industry is asked to participate by developing and sharing best practices for subgroup participation in clinical trials. The FDA is organizing a steering committee to implement the plan, devise metrics to measure progress, and provide a full report at a public meeting in 18 months.

Final Guidance

Along with the action plan, the FDA is publishing final guidance titled, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” Though the guidance is written with medical devices in mind, many pharmaceuticals are used in conjunction with medical devices so some information in the guidance may be applicable to drug sponsors. Ms. Hamburg states, “Certain medical devices may yield different responses in women than men, and yet women are under-represented in some medical device studies.” This statement is certainly true for drug and biological treatments as well.