The Food and Drug Administration (FDA) has made progress on its Action Plan, published in August of 2015, to improve participation in clinical trials.
The three areas the FDA focused on were reporting, analysis and data collected in demographic subgroups, opening up participation in clinical trials, and providing clear and precise subgroup data.
As outlined on a blog post written by Dr. Barbara D. Buch, chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research, on the FDA website, methods to improve the analysis and collection of data in demographic subgroups include the FDA administering guidelines through staff training, updating MedWatch forms that will help with the collection of demographic information, a plan created by the Office of Minority Health to better understand clinical outcomes in racial/ethnic groups, and the Office of Women’s Health providing a “Research Roadmap” for its strategy on women’s health research.
Some of the ways the FDA are broadening participation in clinical trials are developing workshops featuring the discussion of diversity in the trials, making demographic information more readily available through their webpage and with articles, and by co-sponsoring a clinical trials workshop with Johns Hopkins.
In regards to more clear and precise subgroup data, the FDA has implemented a group designed to improve communication strategies, making demographic information obtainable by physicians, and by modifying online documents to ensure certain key information is included.
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