Associate Professor Joshua Schwartzstein
(Photo by Russ Campbell)

Associate Professor Joshua Schwartzstein
(Photo by Russ Campbell)

As it turns out, innovation doesn’t benefit everyone equally, and a new study tries to understand how that plays out in the pharmaceutical R&D process in the United States. “The numbers are striking,” says Associate Professor Joshua Schwartzstein, pointing to the fact that Black patients represent only about 5 percent of participants in clinical drug trials.

In the working paper, “Representation and Extrapolation: Evidence from Clinical Trials,” coauthors Marcella Alsan, Maya Durvasula, Harsh Gupta, Heidi Williams, and Schwartzstein looked at the causes and consequences of the racial gap in the clinical approval process. In a survey experiment, the researchers found that 72 percent of doctors had been asked by their patients whether a new drug would “work in people like me.” Black patients and the doctors who treat them put less faith in trial evidence when the drug is tested on a population that lacks representation, according to the coauthors’ findings.

The study suggests a downward cycle, with widespread implications for racial disparity in health outcomes. “If you are underrepresented and lack confidence that the results apply to you, then you may be harder to recruit for clinical trials,” Schwartzstein explains. That in turn could lead to lower levels of representation in clinical trials and less data on Black patients.

Actually increasing representation in trial populations could help break the cycle, Schwartzstein says. If Black patients were included proportionally, the trend could improve: Study findings suggest that doctors would be much more willing to prescribe that medication to Black patients—with no negative effect on white patients, Schwartzstein adds. The results suggest that a big investment to increase representation in the short-term might help increase it in the long-term.

Of course, increasing representation in clinical trials comes with a cost: It takes more time and investment to recruit population samples that better reflect society. “It’s a practically important problem with a lot of complexity,” Schwartzstein concludes.

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