The U.S. Food and Drug Administration has released an action plan for enhancing the collection and availability of clinical trial data on demographic subgroups, including patient populations divided by sex, age, race and ethnicity.
We know that richer information is collected when different subgroups are enrolled in pivotal studies for medical products, writes Margaret Hamburg, M.D., FDA Commissioner in an Aug. 20 blog post. This kind of enrollment in turn gives us greater assurance in the safety and effectiveness of the medical products used by a diverse population.
The FDA believes that greater representation of diverse patient populations in applications for FDA-regulated medical products is beneficial. By improving data quality, encouraging greater participation in clinical trials, and making demographic subgroup data more available and transparent, we can help to ensure that researchers, health professionals and consumers will have easy access to meaningful clinical information about medical products that will help them make informed decisions, according to the plan.
The Food and Drug Administration Safety and Innovation Act of 2012 directed the FDA to develop a plan for improving the quality of analyses of data on demographic subgroups. The regulatory agencys plan has 27 action items designed to meet three overarching priorities that will be implemented over five years. The priorities are to improve the quality of data collection and analysis, identify barriers to subgroup enrollment in clinical trials, and make subgroup data more transparent.
In addition to the action plan, FDA has published final guidance that includes recommended methods for clinical study design and conduct to increase enrollment of men and women, if needed, and ways to analyze data for gender differences.
It was written in response to the fact that certain medical devices may yield different responses in women than men, and yet women are under-represented in some medical device studies, writes Hamburg. This has led to less information for women regarding the risks and benefits of using these devices.
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