Study: Clinical Trials Need to Improve Reporting of Participant Social Determinants of Health

May 27th, 2021

By Jill Drachenberg, Editor, Relias Media

Although the reporting of participants’ race in clinical trials has improved, much work is needed for consistent reporting of socioeconomic status (SES) and sex, the authors of a new study concluded.

SES, race, and sex are important social determinants of health, the authors noted. Even so, these factors often are underreported in clinical trials, and minority groups are underrepresented.

To determine changes in reporting, the researchers studied 688 clinical trials in 2015 and 2019. Nearly half of trials in both years reported race — a vast improvement over 1999 statistics, which found only 28.7% of clinical trials reported race. However, most of the participants were white, accounting for 84% in 2015 and 77% in 2019. Fewer than 15% of studies (14.7% in 2015 and 12.3% in 2018) reported SES. Sex was noted in 98% of the clinical trials, although the median number of female participants was 46%.

“We found that limited progress has been made in the reporting and representation of race and SES within medical research between 2015 and 2019, while the reporting of sex was high,” the authors concluded. “The impacts of systemic racism in medicine are being acknowledged. It is imperative that we now address this important problem and improve the way we represent, report, and include race, SES, and sex in medical research.”

But overcoming systemic racism is not a matter of simply recruiting more diverse clinical trial participants. A long history of racism can lead to mistrust in communities of color.

“All of these things reflect a structure, a process,” Clyde W. Yancy, MD, MSc, vice dean of diversity and inclusion for medicine, professor of medical social sciences, and chief of the division of cardiology at Northwestern University Feinberg School of Medicine, noted at a recent webinar. “The way an IRB functions, the way protocols are disseminated, the way studies are funded, the way investigators are rewarded, particularly with academic credit, all of this is within a fairly strict system. That system, by design, whether it was overt or not, excludes certain important constituencies. When we talk about structural racism, we’re saying that there’s something inherent in the design of our systems whereby the execution of that process unfortunately leaves some people out of the equation. We shouldn’t fear the phrase ‘structural racism.’ We should recognize it as an invitation to re-evaluate our processes and [ask], ‘Have we developed processes that are more inclusive?’”

Including diverse populations in clinical trials also ensures good science and safe medications. “[When] we create representative populations in our clinical trials, we create better science,” PRA Health Sciences chief scientific officer and executive vice president Kent Thoelke said at the same webinar. “We create safer drugs. We create better understanding and profiles around the efficacy of the drugs for testing, so this conversation is an incredibly important one.”