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Earlier this year, a bipartisan bill was introduced in the US congress to increase diversity in clinical research trials. The DEPICT act, as it’s called, has many major changes to how clinical trials would be conducted. These changes would affect sponsors, the government, and clinical research sites. Sponsors are the companies which develop new drugs and devices in clinical trials.
The bill would require new demographic analyses for drug and device trials by sponsors. Demographic data includes age, sex, race, and ethnicity. Sponsors would investigate the rates of a disease among demographic groups before starting a trial. They would then devise a diversity action plan. This ensures the clinical trial includes a representative sample of the affected population. Let’s say a drug targeted lung cancer, for example. The sponsor would have to find out who has increased chances of getting lung cancer. If they found that Black Americans were at higher risk, they would make a plan to ensure this group was included in any research trials. Plans could include community outreach, specific site selection, and diversity training.
A key aspect of the bill is discovering how to best reach diverse communities. Research sponsors would need to submit annual reports. These would outline how successful their studies were at reaching the demographic goals. If they failed to meet goals, they would give possible reasons they did not. The Food and Drug Administration (FDA) would compile and analyze the reports. The FDA would issue public reports on diversity and enrollment targets. They would also publish justifications for failure to meet targets and recommendations to solve this. Additionally, the National Institute of Health (NIH) would provide outreach. For sponsors, they would issue best practices for increasing diversity. They would engage with minorities to bring awareness of clinical research trials. They would also help local organizations inform their community about research trials.
The final piece of the bill is increasing access. The bill would enhance clinical research infrastructure in underserved communities. The bill provides grants to expand clinical research facilities. These would be in rural areas, on Indian tribal lands, and in federally recognized underserved communities. The grants would help facilities conduct research trials in these areas.
Altogether, this bill addresses the shortcomings of clinical trials in diverse communities. It closes the gap between who suffers from medical conditions and who participates in clinical research trials. It helps find out which methods increase clinical trial diversity. It also helps expand access to clinical trials in underserved communities. There is still a long way to go before this bill makes it to the voting floor, but it’s a good step.
Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience
Text – H.R.6584 – 117th Congress (2021-2022): DEPICT Act. (2022, February 3). https://www.congress.gov/bill/117th-congress/house-bill/6584/text