Clinical trials are not always an accurate representation of patient populations. In fact, clinical trials often have a very long list of inclusion and exclusion criteria wherein the aim is to select a uniform cohort of patients, but an unintended consequence of such is that this criterion inevitably creates a group that is not an accurate representation of real-world patient populations. Both regulators and sponsors are aware of this, and in fact, recent years have seen a greater emphasis on RWE (real-world evidence) data, usually collected after the marketing authorization of any new drug.

A recent article in the New England Journal of Medicine highlights the importance of enrolling a wider, more diverse patient population in Phase III trials, which will be submitted to regulatory authorities for any future NDA approval. Of note, the new legislation requires these data to be collected before, and not after, the marketing authorization has been granted.

“In June 2022, the U.S. House of Representatives passed a legislation intended to increase the diversity of the populations enrolled in clinical trials of new drugs. Under this bill, study sponsors would be required to submit a diversity action plan — including goals for study enrollment according to demographic group and steps for achieving those goals — for phase 3 or pivotal studies of new drugs. These diversity provisions, considered as part of a broader reauthorization of user-fee funding of the Food and Drug Administration (FDA), would codify recent FDA draft guidance recommending that clinical trial sponsors develop and submit diversity plans for enrolling participants from historically underrepresented racial and ethnic populations. The legislation and draft guidance followed an executive order from President Joe Biden directing federal agencies to review barriers and potential new policies for advancing equity in agency actions and federal programs.”1

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References

  1. Hwang, T. J., & Brawley, O. W. (2022). New Federal Incentives for Diversity in Clinical Trials. New England Journal of Medicine, 387(15), 1347–1349. https://doi.org/10.1056/nejmp2209043

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  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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