Clinical Trials Diversity and Inclusion

As we know, the pandemic brought the topic of clinical trials to the forefront of the general population. Never before have people been exposed to daily news from the mainstream media on clinical trials, the therapies in trials for COVID-19 and the need to have data that supports efficacy and safety of these therapies, which are generated from clinical trials. Further, when Moderna briefly halted its vaccine trial to ensure that data from broad, diverse populations was included, did people understand the importance of trials including all population groups. The clinical trials industry itself has struggled with the inclusion of underrepresented groups for some time and is not blind to this multi-faceted problem.

In this issue's main feature, Applied Clinical Trials explores what the term "diversity" can mean when studying different populations. It also points to technologies used in decentralized trials as a way to reach underrepresented populations and allow them to participate in a clinical trial. If we struggle to include an underrepresented population in clinical trials, then those who suffer from rare diseases could certainly be a part of such a discussion. In another article, we learn that rare disease patients were disproportionally affected with healthcare access during COVID and that technologies could improve both their access to healthcare, as well as clinical trials. We have also included an article that informs on the five ways that decentralized trials can positively impact clinical trial diversity.

We applaud industry stakeholders—sponsors, CROs, investigative sites, and technology providers—on focusing their attention on the diversity and inclusion issue. Many have come forth with important programs and resources to improve the situation. However, as Pfizer executives penned in a letter, "Racial and ethnic disparities in clinical trial populations remain unacceptably abundant, and trust in the health-care system among those who suffer racial injustice is low. It is difficult to find a trial and the requirements for participants are often burdensome, contributing to unacceptably high dropout rates." They call on the stakeholders "to find common solutions that build trust and address the socioeconomic barriers to clinical trial participation." They elaborate on the specific commitments to improve clinical trial access and build trust, and to improve awareness. Hopefully, the articles in this issue will help industry in these endeavors.

Mike Hennessy Sr., Chairman and Founder, MJH Life Sciences