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In the Effort to Diversify Clinical Trials, Trust, Access, and Education Play Crucial Roles

Kelly Davio
While funders and researchers have long held that clinical trials should enroll more diverse patients to better reflect the populations in which approved drugs will eventually be used, patient populations enrolled in clinical trials remain largely homogenous.
While funders and researchers have long held that clinical trials should enroll more diverse patients to better reflect the populations in which approved drugs will eventually be used, patient populations enrolled in clinical trials remain largely homogenous.

As Todd C. Knepper, PharmD, and Howard L. McLeod, PharmD, both of Florida’s Moffitt Cancer Center, reported in a comment recently published in Nature, in 1997, 92% of participants in clinical trials for treatments targeting cancer, central nervous system diseases, and heart disease were white. By 2014, that percentage was not much better, with white patients still comprising 86% of participants.1

Given the fact that drugs may behave differently in different patient populations, homogenous trial populations are likely hindering the development of effective therapies, whereas trials that enroll more minority patients may lead to conclusions that might not otherwise have been discovered.

For example, the FLAURA trial, which enrolled a high number of Asian patients with non–small cell lung cancer (NSCLC), demonstrated that osimertinib was more effective than standard therapy in treating EGFR-mutated NSCLC, a disease type that affects more Asian patients than white patients. Similarly, the Abi Race clinical trial of abiraterone in black men—who are more likely to die of prostate cancer than are white men—with advanced prostate cancer demonstrated that the therapy was linked to a greater decline in prostate-serum antigen in black men than in their white counterparts.

While clinicians may agree that it is crucial to enroll diverse patient populations in clinical trials, they face significant challenges in doing so. James Hamrick, MD, senior medical director at Flatiron Health, told The American Journal of Managed Care® that, in part, minority populations have what he termed a justified skepticism about research participation, and pointed to the infamous Tuskegee Syphilis Study—in which black men were denied effective treatment for syphilis in order for government researchers to document the natural history of the disease—as one tragic example of reasons why minority patients might avoid research.

But furthermore, Hamrick said, patients who might be willing to participate in a clinical trial may lack access because of location and/or socioeconomic status. Providers who are caring for patients in rural practices may not be suggesting trials to their patients, in part because patients in these areas might have to travel to a major academic center for monitoring.

“If the patient doesn’t have the freedom from getting off of work or having a family member or friend help with the time and cost associated with travel, that’s going to self-select for a more affluent population, so there are some real barriers there,” according to Hamrick.

In order to address the problem of access, Hamrick says, trials need to be available closer to home for more patients: “We have to bring the trial to the patients as opposed to bringing the patients to the trials.”

Keys to achieving this objective include designing trials that can be conducted in smaller centers and clinics outside of academic centers so that trials can become more a part of patient care rather than a disruption for patient populations who may lack resources.



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