Diversity in Clinical Trials: A Blog Series

We are pleased to bring you a new series on “Diversity in Clinical Trials”

It’s universally understood that the biggest problem in clinical research is recruitment and retention — recruiting an adequate number of patients on time and keeping them engaged in the study to completion. But how to successfully engage with patients from diverse populations? To gain the latest insights on the impact, challenges, and strategies, we are pleased to bring you a new series on “Diversity in Clinical Trials” with Jennifer Lannon, Director of Partnerships and Business Development, Patient Advocacy at Alira Health.

Part 1: The Impact of Underrepresentation of Diverse Groups in Clinical Trials

Current data shows that diverse groups continue to be underrepresented in clinical trials. According to FDA data, in 2020, on average 75% of the 32,000 participants in clinical trials for 53 novel drugs were white; only 11% were Hispanic and 8% were Black (while those groups represent 18.9% and 13.6%, respectively, of the population according to US Census data). This is not unusual; historically, the majority of drugs have been tested on white male participants. How does this play out? A lack of diversity during clinical trials has a major impact. | Read Now

Part 2: Challenges to Creating Diversity in Clinical Trials

Now that the FDA has a mandate requiring trial sponsors to include a diversity action plan in their clinical trials, it’s vital that companies comply. This is not only in their business interest but also in the interest of Americans’ health. But what challenges do pharmaceutical and biotech companies face when it comes to representation of diverse groups in clinical trials? | Read Now

Part 3: How Can Clinical Trials be More Inclusive?

How can teams successfully engage with patients from diverse populations? If sponsors engage with these underrepresented groups to create trials that work for them, they can open up access to new trial participants. And given the new law that recently passed (Public Law 117-328), pharmaceutical and biotech companies will soon be required to provide a diversity action plan documenting how they will recruit more diverse populations to their trials. Expanding diversity in trials is not just the right thing to do; it’s now becoming mandatory. | Read Now