HIT Consultant June 29, 2023
Trial sponsors have made efforts to address underrepresentation and promote Diversity, Equity and Inclusion (DEI) in clinical trials since the Federal and Drug Administration’s (FDA) 2016 guidance, but a new report released by the Government Accountability Office (GAO) still shows a continuous presence of major gaps in patient diversity. It begs the question: how do we ultimately achieve full representation and ensure accountability to uphold the promises we have made for patients?
As the industry transitions from receiving guidance to now having to abide by formal legislation requiring diversity action plans – moving from intention to action – sponsors will have to re-evaluate their processes and how to address this long, overdue industry challenge. If they don’t act now, it...