In June, the FDA released a draft guidance aimed at enhancing diversity in clinical trials by encouraging companies to develop Diversity Action Plans. These plans are intended to increase participation from underrepresented populations, addressing factors like race, ethnicity, sex, and age in drug and device trials. As part of their Investigational Device Exemption (IDE) applications, companies will now need to outline enrollment goals for these demographics and strategies to achieve them.
While this guidance is not yet fully implemented, FDA’s Center for Devices and Radiological Health (CDRH) representative, Dr. Tarver, stressed that now is the time to begin formulating diversity plans. He advised companies to seek feedback early, to gain a clearer understanding of what their diversity plans should look like.
According to Tarver, the FDA has already received a significant number of these diversity action plans, signaling early engagement from industry stakeholders.
Tarver also underscored the role of patient feedback in the trial process, referencing the FDA’s 2022 final guidance on patient engagement. This focus on patient input has already led to modifications in clinical trials and improved communication strategies to increase participation.
Ultimately, Tarver urged companies to think about ways to improve patient adherence and participation in trials. He emphasized the need for diversity plans to support inclusion without creating additional barriers for underrepresented groups. The underlying goal is to ensure that these efforts enhance rather than complicate clinical trial participation.
So, is the FDA really pushing for DEI in clinical studies?
The answer appears to be a resounding yes, with concrete steps being taken to integrate diversity and patient-centered approaches into the heart of clinical trial design.