A couple of years ago, I signed up for the All of Us research program, an NIH-sponsored project to collect and study data from more than a million people in the United States. Over the years, I have joined some clinical trials, mainly to receive free or low-cost medical care. But this program was different; it was an opportunity to impact the understanding and treatment landscape for various diseases potentially. The program was also an opportunity to help correct some of the inequities in the clinical trials space.
For entirely too long, clinical trials primarily enrolled white men (mostly young and middle-aged). A 2017 report from the U.S. Food & Drug Administration (FDA) found that 48% of trial populations include women, only 7% of trial participants are Black, and about 21% are over 65. In some trials, 80-90% of trial participants are white. That’s just not representative of the United States, where at least 40% of Americans identify with a race or ethnic group other than white.
Lack of representation can severely impact, particularly when the medication is being tested to treat a vulnerable population. For example, 91% of patients participating in a trial for the only FDA-approved medication to treat hallucinations in Parkinson’s disease were white; only 1% were Black.
Have clinical trials always been this way?
Before IRBs (Institutional Review Boards — the groups that review and monitor biomedical research involving human subjects), medical research was kind of like the wild west. While this time led to an incredible understanding of how the human body works, the methods used by clinicians were deplorable.
Well-known cases like Lucy — an enslaved woman who had gynecologic surgery performed on her without anesthesia by the “father of modern gynecology,” Henrietta Lacks, and the Tuskegee syphilis experiment are just the tip of the iceberg. For decades, scientists used children, the poor, prisoners, and other marginalized communities to conduct medical research.
Over the years, government agencies began implementing regulations to prevent abuse or potential harm to many underrepresented communities. For example, in 1977, the FDA banned most of “childbearing potential” from participating in clinical research studies due to drugs like thalidomide (a sedative often given to pregnant women to treat morning sickness) causing severe congenital disabilities. Within a few years, a task force on women’s health recognized that this ban could potentially mean that life-saving drugs may not work or not work as well in women as they did in men. By 1985, the FDA issued new guidelines encouraging more inclusion of women in studies.
But the damage was already done. Government analyses found that women were still significantly underrepresented in essential studies.
How are organizations working to fix the diversity issue?
The government made several attempts to correct the diversity issue in clinical trials. In addition to formally rescinding the ban of most women from clinical trials in 1993, Congress also passed the NIH Revitalization Act of 1993, which directed the NIH to establish guidelines for including women and minorities in clinical research. To receive NIH funding, trials are supposed to meet the diversity guidelines set by the NIH. Through projects like All of Us, researchers will potentially have access to more diverse biological information, which can inform the early phases of clinical research and development.
However, funding projects and rescinding policies don’t address the issues of mistrust that some communities — primarily Black and indigenous people — have. Some pharmaceutical companies (and healthcare organizations) are trying to address the issue of mistrust by addressing their internal diversity problems.
Recently, Novartis Pharmaceuticals made a 10-year commitment with 27 Historically Black Colleges, Universities, and Medical Schools to invest $37.7 million in the next generation of leaders in health, science, technology, and business. The funds include a $13.7 million investment in three digitally-enabled research centers at Morehouse School of Medicine, including a clinical trial center of excellence to increase diversity among clinical trial investigators and participants.
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