A Dangerous Slope for the Future of Clinical Trials and Innovations in BioPharma
I’m starting this post by quoting Jeanne Regnante, a health equity life sciences consultant at Patient 3i LLC. She recently reiterated that “Poor representation in clinical trials reduces our understanding of drug responses and safety for all groups.” I believe this sets the tone for where the progress of healthcare and future innovations in biotechnology are headed if more entities continue jumping on the bandwagon that intentionally imparts and weaves discrimination throughout society.
Regnante’s response is as clear as it gets yet, the U.S. Food and Drug Administration (FDA) has recently removed draft guidance from its website that encouraged pharmaceutical and medical device companies to include diverse populations in clinical trials. This action results from an executive order from the Trump Administration aimed at dismantling diversity, equity, and inclusion (DEI) policies across federal agencies and contractors.
“The FDA’s “Diversity Action Plan draft guidance” to drug and medical device companies stems from the 2022 Food and Drug Omnibus Reform Act.
It aims to significantly increase participation of underrepresented groups, including African American and Hispanic Americans, in clinical trials, recognizing that most available evidence is based largely on white patients and therefore will not account for differences in how drugs and devices work or what side effects they will cause in various populations.”
This recent rollback of diversity initiatives in clinical trials marks a concerning return to an era when people of African descent and other marginalized groups were largely excluded from medical research. Historically, clinical trials often failed to account for the unique genetic, environmental, and socioeconomic factors affecting these populations, leading to disparities in treatment efficacy and safety.
“Poor representation in clinical trials reduces our understanding of drug responses and safety for all groups.”
The now-removed guidelines aimed to rectify these long-standing inequities by promoting greater inclusivity in research participation. Without such measures, there is a real risk of reverting to outdated practices and societal norms that ignored the health needs of diverse communities, ultimately reinforcing systemic health disparities.
Ensuring diversity in clinical trials is crucial for understanding how medical products affect various populations. These recent actions will have significant implications for the inclusivity and comprehensiveness of future clinical research.
Sources: