GSK's retrospective trial diversity study shows there's more work to do

What if the biopharma industry used epidemiology data, rather than the U.S. Census Bureau to build clinical trial rosters? GSK put the idea to the test in a 17-year retroactive study of clinical trial data from 495 trials, finding that there’s plenty of work to be done to ensure clinical research is representative of the patients who suffer from diseases.

For instance, GSK found that enrollment of Black or African Americans for asthma was 23%, exceeding both census and epidemiologic levels of the disease, at 13% and 17%, respectively. For HIV trials Black and African Americans enrolled at 35%, which was way below the actual disease burden of 55%.

The study, released in Clinical Trials: Journal of the Society of Clinical Trials Monday morning, looks at clinical trial demographic data from nearly 500 studies conducted by GSK and ViiV Healthcare, the pharma’s HIV joint venture with Pfizer. GSK aimed to investigate the historical representation of U.S.-based participants and compare demographics with real-world disease epidemiology data, instead of U.S. Census Bureau race and ethnicity data, which is standard.

GSK found it has more work to do, admitted Christopher Corsico, senior vice president of development, in a release. But the U.K. pharma hopes that by putting the data out into the public, other companies can learn how to do better, too.

“To make meaningful progress on diverse participation in clinical trials, we need meaningful collaboration with regulators, patients, academia, other biopharma companies and the wider healthcare ecosystem so that together we can achieve a shared goal of better health outcomes for all,” Corsico said.

While GSK did pretty well matching the U.S. Census Bureau benchmark, the study suggests that the pharma industry consider a shift to epidemiological data when setting goalposts for diverse enrollment in clinical trials.

GSK has already done work to boost representation in clinical trials. By the end of 2022, all of its phase 3 trials had diversity plans in place to find patients who are most affected by a disease based on epidemiology data. The pharma is also working on ways to overcome barriers to participation, including access to transportation, language differences, lack of trust and awareness.

The company is not alone in this mission. Many major pharmaceutical companies, including Roche, Novartis and Sanofi, have taken steps in recent years to engage with community groups and fund initiatives to boost diversity in trials. But progress has been slow, as trials with these new initiatives may take years to read out.

FDA Commissioner Robert Califf, M.D., urged the industry to do more at a December event, as the agency prepares updated guidance on the issue.