Barbara D. Buch, M.D., Chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research, recently posted on FDA Voice her reflections on a focused action plan to support inclusion of diverse populations in clinical trials. The plan focused on addressing quality, participation and transparency of data in clinical trials.
For improving quality of data collection, progress was reported in training and outreach of guidance on demographic data, modifications to clinical review templates for better inclusion of diverse populations, and more.
To meet the goal of increased participation, Dr. Buch shared that a workshop was held to discuss the importance of diversity in clinical trials, and she reported that clinical trial demographic information is now easily available online for consumers.
To improve transparency, FDA reported that a Language Access Plan Working Group was established for new communication strategies to reach those under-represented, and a pilot program was formed to make demographic information available for Biologics License Applications, and more.
Read Buch’s entire article here for more details on the progress made. Contact Pearl IRB for experienced assistance in your clinical research.