A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases.
GSK’s retrospective study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the period 2002 to 2019.
It is hoped the results will inform how clinical trial sponsors can better design research to represent the diversity of real-world patient populations, given that some diseases disproportionately impact certain racial and ethnic groups.
The safety and efficacy of medicines and vaccines can differ based on genetic or environmental factors, and appropriate representation in clinical research is critical for advancing our understanding of new medicines and vaccines to ensure they have the biggest impact on patients.
The study confirmed that in four disease areas (asthma, COPD, HIV and influenza) census data differed from the epidemiological data. For example, US Census Bureau data indicates 13.4% of the population is Black/African American while the prevalence of asthma among this group in the US is 17%.
It also showed that GSK trial enrolment for each condition differed by race and ethnicity. For example, in HIV trials, enrolment of Black/African Americans at 35.1% markedly exceeded census levels of 13.4% but underrepresented epidemiologic levels of 55.3%.
Christopher Corsico, Senior Vice President, Development, GSK said: “While we have more to do at GSK, today’s publication offers important new data and analyses for sponsors to consider when planning their clinical programmes. 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.”