A Need for Action

In recent years, Applied Clinical Trials has featured an issue theme in its editorial calendar solely focused on diversity in clinical trials. The topic coverage typically constitutes one of our most well-read editions of the magazine, along with its companion online focus category diversity, equity, and inclusion (DE&I) on our website. This March 2024 edition of ACT once again features a number of perspectives on where the clinical trials industry currently stands in its efforts to improve diversity and patient representation related to study planning, design, and execution.

Notably, in a recent conversation with editor Andy Studna, Advarra CEO Gadi Saarony said that diversity in clinical trials is “not where it needs to be.” Saarony emphasized a need for action throughout the interview. While the industry has done a commendable job to raise awareness around diversity, what are the necessary next steps—for all parties involved—in taking action and improving diversity in trials?

To that end, our March feature coverage begins with an executive roundtable-type discussion convened by Rohit Nambisan, CEO and co-founder of Lokavant. The dialogue focuses on the Food and Drug Omnibus Reform Act (FDORA) and how drug developers will need to respond to its demand for "prioritization of representation" in clinical trials. One avenue, the experts share, is through the cost-efficient use of AI and advancing digital health technologies.

Our second feature provides a good segue into potential ways companies can design their trials to be more diverse; the article presents six steps to constructing a successful protocol diversity plan. Next is an exploration of DE&I—and its three critical components—from a 360-degree view. In strategizing a trial outreach plan, the feature considers multiple factors, such as site location, looking beyond inclusion/exclusion criteria for patient recruitment, and engaging patient advisory boards. Rounding out our feature articles on diversity this month is a piece on utilizing a "human-centric" approach to support more representative populations and the goal of better health outcomes. Tapping tools such as AI and machine learning, hyper-localized approaches for recruitment, and patient-support services are all discussed.

We are also happy to share new content from the recent Summit for Clinical Ops Executives (SCOPE) conference. Our editors on-site and back at home provided coverage of breakout sessions and conducted on-site interviews with key opinion leaders. Full coverage can be found at appliedclinicaltrialsonline.com/latest-conference.

As always, thank you for reading.

Mike Hennessy Jr, president and CEO, MJH Life Sciences®