Increase Diversity in Clinical Trials

Discussions around improving diversity in clinical trials have been ongoing for quite some time, with relatively gradual change to actual practice. The April publication of the FDA’s guidance on achieving these goals however, and the more recent appropriations bill approved in December, have begun to codify these recommendations as legal requirements. In the short run, this represents change and cost to our industry, as we modify startup SOP’s, change recruitment strategies, and onboard new technologies. But increasing diversity in trials downstream produces better science, more efficient trials, and, most importantly, more equitable outcomes in medicine.

Because it is Black History Month, we’d like to draw attention to a well cited article in the JCO Oncology Practice journal that does an excellent job of highlighting some of these points. In it they outline that in the case of multiple myeloma (MM), Black Americans account for about 22% of cases annually, while only representing 4.5% of the median enrollment percentage. This low participation to prevalence ratio has been widely observed across all cancer subtypes. It is a perfect example of where a lack of trial diversity is both hurting under represented populations, and the quality, safety, and efficacy of the therapies being researched. The paper details a variety of barriers that stand in the way of more inclusive clinical research, and proposes a variety of strategies being employed to address them.

Diversity in trials promises to provide more equitable access to the most modern clinical therapies, and that those therapies will be properly tested in regards to safety and efficacy across a larger swath of the human population. Providing this access as an industry holds the promise of a larger and more inclusive body of patients participating in clinical research; globally, more than 80 percent of trials fail to enroll on time.

Making good on this initiative produces a more inclusive system of clinical research, one that solves new problems quicker, and produces better and safer outcomes of us all.