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

By Maria Marabito, Healio

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. Read more …