Researchers call out Gilead over diversity of remdesivir trials

COVID in California
In a 397-subject clinical trial sponsored by Gilead, 11% of the participants were Black Americans. (Getty Images)

Researchers have called for sponsors of COVID-19 clinical trials to run more diverse studies. The call follows an analysis of Gilead’s remdesivir clinical trials that found the studies “failed to provide equal representation of Black, Latinx and Native Americans.”

Writing in the New England Journal of Medicine, the researchers cite data showing Black Americans account for a disproportionate number of COVID-19 cases in the U.S. In Alabama, for example, Black or African American people make up 27% of the population but account for 43% of cases. Hispanic or Latino people are also overrepresented in COVID-19 case data in Alabama and other states.

The data suggest approved COVID-19 drugs will be used extensively in Black, Latinx and Native Americans. Yet, the researchers found data supporting the efficacy and safety of remdesivir, an early COVID-19 drug, in minority groups “are limited.”

Virtual Roundtable

ESMO Post Show: Highlights From the Virtual Conference

Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields.

That claim is based on an analysis of the demographics of the subjects in several remdesivir datasets. In a 397-subject clinical trial sponsored by Gilead, 11% of the participants were Black Americans. The figures are higher for other studies—20% of the 1,063 subjects in the National Institute of Allergy and Infectious Diseases’ Adaptive Covid-19 Treatment Trial were Black—but still too low in the view of the researchers.

“The modest benefit seen in time to clinical improvement with remdesivir may not be generalizable to minority populations, given the differences in disease severity and outcomes,” the authors wrote.

A lack of diversity in clinical trials is a long-standing problem that has persisted despite federal law mandating the inclusion of minorities in government-funded research. The persistence of the issue in COVID-19 clinical trials has prompted the researchers to push for change.

The authors of the NEJM piece want the sponsors of Covid-19 clinical trials to “prioritize inclusion of patient populations that reflect the demographics of the ongoing pandemic.” With that goal in mind, the researchers are advocating for “appropriate random sampling and the expansion of clinical trial sites to vulnerable communities with high-risk patients.”  

Suggested Articles

Novartis is forging ahead with the development of spartalizumab in "many, many other indications" despite the setback.

Chi-Med has detailed plans to seek approval from the FDA later this year in part on the strength of data from Chinese phase 3 trial.

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.