FDA Would Like Inclusion of Pregnant Women in Clinical Research: Easier Said Than Done
(Thursday, July 22, 2021)
Pregnant women are almost always excluded from clinical trials and pregnancy is usually considered an adverse event leading to dropping women from ongoing clinical trials. FDA, along with European regulators, would like to change that. But it is not easy to implement. There is no law that could mandate inclusion of pregnant women in clinical trials, and it is too risky for a developer to include such highly vulnerable population in their clinical trials, not to mention finding pregnant women willing to participate in a clinical trial with a new drug. This is an issue with any vulnerable population, be it children, minorities, or other disadvantaged population sub-groups that are mostly absent from clinical trials with new products despite the obvious need of the opposite. Not to belittle the importance of developing and evaluating treatments for vulnerable populations, it is not a simple issue of asking developers to test their drugs in pregnant women or any other vulnerable group. Clinical trials, at least those for new products, are perhaps not the best setting to evaluate new drugs in such populations. There is need for common sense regulatory approaches to approve drugs for such populations. A blog this week by FDA’s internal experts acknowledge the challenges with testing drugs in pregnant women. They list four guidance documents released recently addressing various issues with pregnant women in clinical trials and describe alignment of resources with European regulators to encourage inclusion of pregnant women in clinical trials. This expands on an article published earlier this year by the same group on the same topic. However, common sense approaches such as using real-world evidence from medical records, registry studies, post-market surveillance, and nonclinical or in-silico research to support expanding approval to pregnant women would perhaps be more palatable to developers. Doctors already use this approach when prescribing drugs to their pregnant patients. Perhaps FDA can formalize a real-world evidence heavy pathway to approval of new treatments for pregnant women. This would still not address the delay in getting new drugs to pregnant women but let that be the decision between patients and doctors where they can decide if a given new drug, that was never tested in pregnant women, is still the best option for a pregnant patient.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
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