FDA reports progress of clinical trial demographic information analysis

In a recent blog post on the FDA website, Barbara D. Buch, MD, chair of the Section 907 steering committee and associate director for medicine at the FDA Center for Biologics Evaluation and Research, discussed the importance of demographic subgroup information in clinical trials and how readily available those data are to the public.

Buch explained that, after completing a review of 72 medical product applications, the FDA published a report in August 2013 acknowledging that it had room for improvement with regard to how well demographic subgroup data were incorporated into clinical trials. As a result, the FDA created an action plan in August 2014 to improve its performance in collecting and analyzing information pertaining to sex, age and race/ethnicity.

The action plan includes 27 items focused on three priorities, which are improving the completeness and quality of demographic subgroup data collection, identifying barriers to subgroup enrollment and employing strategies to encourage greater participation, and improving the public availability of demographic subgroup data.

In her post, Buch described the many strides the FDA has made thus far to accomplish the three priorities.

These strides include the launch of the Drug Snapshots web page, which extracts demographic subgroup data for FDA-approved products. The web page includes information on study participants, study design, efficacy and safety results, as well as the differences in side effects and benefits among various sex, race and age groups, according to Buch.

The FDA has also initiated education and training for reviewers with regard to demographic inclusion, analysis and communication of clinical data.

Among other changes, the FDA has established a joint working group with the National Institutes of Health to create a framework for collaboration and the exchange of information on inclusion policies, practices and challenges.

Buch stated that a public meeting will take place in early 2016, aimed to help the FDA gain insight and feedback in its quest to more fully integrate patient demographics into its review of medical products. – by Abigail Sutton

Reference: blogs.fda.gov.