In the first part of our two-piece series exploring minority participation in clinical trial research, we examine the numerous challenges to securing diversity in clinical trials, and the consequences of primarily white patient populations. Our second piece details how we successfully recruited a diverse population for a recent blood pressure trial.
The Disheartening Statistics
Black subjects make up a mere five percent of the total clinical trial population. The most egregious underrepresentation of minorities occurs in cancer research, despite the disease having the highest incidence and mortality rates among black patients . Take for instance, Ninlaro, a cancer drug approved by the FDA in 2015. Clinical trial testing for the drug yielded 722 participants, of which only 13 (1.8 percent) were black patients.
Differences in characteristics such as age, ethnicity and race play a role in a drug’s efficacy. Minority groups sometimes require a different dosage, or a different drug entirely than that of those in the majority population. By not ensuring a diverse trial, sponsors miss out on the opportunity to increase understanding on “…effectiveness and safety of therapies for the broader population.“
The Challenges in Recruiting Minorities
Why is the clinical trial industry neglecting entire classes of race, even when we understand that race is a determining factor on efficacy?
Now that we’ve identified some of the impediments to achieving diversity among the clinical trial population, it is important to analyze potential solutions. The next piece in our series will do just that, providing a specific case study, outlining how we recruited a trial population comprised of 60 percent minorities.