COVID-19 pandemic led to more inclusive practices in clinical trials

Clinical trial sponsors said they have adopted new methods and decentralized procedures that may increase diversity and inclusion in future trials.

The changes were prompted by the COVID-19 pandemic, which dissuaded trial participants from attending in-person evaluations and follow-up visits, according to panelists at Fierce JPM Week, a meeting that brought industry experts together to discuss the future of pharma and health care.

“The pivotal moment when we realized something was going to be different was when the number one topic from investigators and field medical staff was the capability of changing trials to a decentralized model,” Gaelan Ritter, the head of analytics innovation and digital health at Bristol Myers Squibb, said during a discussion. “When that shot up the ranks from not being discussed much at all to being the primary point of discussion, we knew something foundational was going to have to change.”

According to the FDA, decentralized clinical trials allow researchers to conduct remote assessments, which help reduce participants’ exposure to COVID-19. This shift toward hybrid models can also improve clinical trial enrollment for diverse patient populations, Ritter said. Previous research has shown that the lack of racial and ethnic diversity in clinical trials is partly attributed to the lack of recruitment in communities. Instead, many trials recruit patients from academic centers.

At Verily Life Sciences, Jessica L. Mega, MD, the company’s cofounder and chief medical and scientific officer, said they also shifted toward decentralized trials and hybrid models to make trials more inclusive.

“We know in many trials we don't have fully representative samples because people who need to come to the clinic may not always be the patients that we treat more broadly,” she said. “And so, we’ve been ... thinking about creative recruitment, and then actually bringing the clinical pathway in that journey into the home.”

By implementing hybrid access to trials, Verily was able to make them more patient-centered, according to Mega.

Similarly, Craig Tendler, MD, the global head of late-stage clinical development, diagnostics and medical affairs in hematology and oncology at Janssen, and colleagues established processes that allowed patients to avoid traveling to study centers, such as by conducting interviews at labs that are closer to the patients and delivering medical directions to patients’ homes.

To make clinical trials more inclusive, Gregory Rotz, advisory leader for pharmaceuticals and life sciences at PwC, suggested looking at the ABCs of clinical trial diversification:

• Awareness of clinical trials among ethnic and racial minority communities.
• Burden on patients, including travel time, time away from work and other factors that often make them inaccessible.
• Confidence in the system.

“Clinical trials are the way that communities get access to the next generation of innovative medicine and investigational products. Having large parts of our population that don't have access, especially if they want to participate in those trials, is a great tragedy for society,” Rotz said.

References:

Advancing oncology decentralized trials. https://www.fda.gov/about-fda/oncology-center-excellence/advancing-oncology-decentralized-trials. Accessed Jan. 20, 2022.

Oishi K, et al. News paths to trial diversity. Presented at: Fierce JPM Week; Jan. 18, 2022 (virtual meeting).