A look at the reported racial composition of device clinical trials is a good news/bad news situation: the inclusion of minority patients appears to be on the upswing, but the overall level of companies reporting such data remains low. We dig into the issue with Epstein Becker Green's Brad Thompson, who provided and helped mine this data.
Health equity is being recognized as an increasingly important issue across all aspects of our healthcare system. In addition to being significant in terms of fundamental fairness in matters such as employment, equity also has clinical implications resulting from the differing safety and efficacy impacts that therapeutic products and procedures can have on diverse racial and ethnic patient populations. Such determinations can only be made by ensuring that clinical trials encompass a real-world cross section of prospective patients. Bradley Merrill Thompson, a member of Epstein Becker Green’s life sciences practice specializing in regulatory law and digital health, including artificial intelligence (AI) and data science, took a look at the racial composition of device clinical trials for Market Pathways, based on information reported by product companies and publicly available at www.clinicaltrials.gov.