DEI Under Trump: What It Means for Clinical Trials

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across different populations. Historically, most approved treatments have been tested primarily on white males, creating gaps in data for other demographic groups.

Despite the removal of DEI-related FDA guidance, clinical trial sponsors, sites, and institutions must consider broader legal and financial risks. The Department of Justice (DOJ) and other agencies are scrutinizing compliance, and organizations receiving federal funding could face funding cuts or legal action for perceived discrimination. Companies must carefully assess the regulatory landscape and determine their risk tolerance while ensuring their trials remain scientifically sound.

Darshan Kulkarni and Edye Edens discuss the rapidly evolving situation, the potential risks for the clinical research industry, and what companies should do to navigate these shifting regulations.

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