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NIH Struggles with Diversity in Clinical Trials Too But Less Than Industry
(Thursday, June 6, 2024) Diversity of the participants in clinical trials has been a hot topic of discussion for the last decade fueled by the anemic data from such populations in market approval applications. So far, most of the focus has been on industry-funded trials but how do government-funded trials fare in their ability to recruit diverse populations? A sampling of NIH-funded trials by the Office of Inspector General (OIG) published last week, shows that NIH too struggles with diversity in its trials, although looking carefully at the data, it seems it does better than industry-funded trials. Ideally, the demographic distribution of clinical trial populations should reflect the populations that would likely use the drug once approved. But far from I; most clinical trial populations are not diverse with almost all demographies, except for Caucasians, being underrepresented. The FDA has initiated several programs to encourage sponsors to increase representation from underrepresented populations in their trials including requiring the sponsors to submit a formal “Diversity Plan” describing specific measures taken to increase participation by underrepresented populations. Although not explicitly indicated, most of these programs are geared towards industry-sponsored trials. But how do the US government agencies fare on this effort? The OIG sampled participant data from 30 NIH-funded Phase III clinical trials for their demographic distribution. About half of these trials did not have an explanation of the planned target population. It found that one-third of these trials did not have a formal “Diversity Plan”. Of the trials that had Diversity Plans, most missed planned enrollment targets for underrepresented groups. NIH requires funded trials to submit annual progress reports which include an inclusion enrollment report (IER) that shows participant demographics by race, ethnicity, and sex. The NIH program officers review the IER and if the IER shows that the planned recruitment goals are not met, ask the funded organization to troubleshoot the issues. Although the program officers have the authority to take administrative steps such as suspending and terminating the study if the corrective actions are unable to address recruitment issues, none of the trials sampled by the OIG were suspended or terminated for not meeting recruitment goals. The OIG report is an interesting primer on the NIH process for supervision of government-funded trials. It shows that NIH-funded trials face similar issues as industry-funded trials in recruiting underrepresented populations. Interestingly, however, the NIH-funded trials fare better than the industry-funded trials with regard to recruiting African Americans and Hispanics. The only groups underrepresented in NIH-funded trials were Native Americans, and Hawaiian and Pacific Islanders. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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