eClinical Tools Can Increase Participant Diversity

By Elias Tharakan, DSG

In April 2022¹, the FDA drafted new requirements for participant diversity in clinical trials, and the U.S. Congress’ 2023 omnibus spending bill requires sponsors to submit diversity action plans. Given the historical disparities in clinical trials, emphasizing diversity is good science and will ultimately benefit the pharmaceutical industry. For example, some diseases disproportionately affect minority populations, so it’s logical to test targeted therapeutics on a proportionate number of participants from that group. However, sponsors already have difficulty recruiting participants, and the new guidelines complicate recruitment. But the correct methodology and technology can help sponsors meet these requirements without additional expenditures and build relationships with minority communities, laying the groundwork for future trials.

Build Community Partnerships

The new guidelines will go into effect in 2024, but the time to plan for diversity is now. Clinical trials take time, so the sooner you plan for recruitment, the better. It’s far simpler to begin with a diversity plan or pivot before the study starts than recreate the trial for new participants later. And although diversity has been a hot topic since the April 2022 draft requirements, few companies offer solid solutions.

¹ FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials | FDA