Eli Lilly believes community-based clinical trials are the wave of the future and is pushing sponsors to embrace the paradigm as a way to boost enrollment and diversity.
“In the future, I think we’ll be predominantly community-based/community-orientated in our clinical research,” Robert Metcalf, Ph.D., Lilly’s senior vice president for clinical design, delivery and analytics, China & Japan Medical, told Fierce Biotech this week, ahead of his participation Tuesday in the FDA’s and Duke-Margolis Center for Health Policy’s public workshop about clinical trial design approaches. “I would hope, by the end of the decade, that community-orientated research and decentralized [trials] are more the norm than they are today.”
Metcalf, who has been with Lilly for over 30 years, has witnessed trials transform from individual investigator sites with paper trails to the digital age of multisite trials and telemedicine. The COVID-19 pandemic brought an urgency to accelerate new paradigms, such as telehealth and wearable tech, that can provide patients more opportunities to be included in clinical research without traveling to a specific location.
“It would be a shame if we didn't continue that paradigm,” Metcalf said. “And so, at Lilly, we see this as a key, what we call community-orientated or community-based research, to continue post-COVID and to really drive a new era.”
The FDA has done a “marvelous job” over the last several years releasing guidance pertinent to the paradigm, according to Metcalf, who cited recent digital health tech, decentralized clinical studies, diversity in clinical trials and study design guidelines.
But guidance isn’t enough. Metcalf urged the federal agency to make changes to regulations, including how certain roles are defined. For example, the FDA’s oversight of clinical investigators (PDF) was last defined in 2000.
“It was developed at the time when everything was single-site, paper-based guidance,” Metcalf explained. If the agency doesn’t update the fundamentals in regulations, it will hold everyone back, the Lilly leader said.
But it’s not just the FDA’s responsibility to make changes. As a sponsor, Lilly hopes to reimagine clinical trial design and improve patient enrollment and diversity through three main avenues.
“The imperative is reaching more diverse patient populations. … I think all of us don't feel great of where we've been historically,” Metcalf said. “We all know that we need to continue to do better.”
To that end, the first approach Lilly is taking is to introduce more innovative trial designs that include new analytical approaches and technologies for reaching more patients.
A particular trial design consideration of Lilly’s is evaluating inadvertent biases that could be seeded among inclusion and exclusion criteria, such as informed consent documents. A large part of that focus centers on linguistics and making sure protocols don't inadvertently discourage recruiting a diverse population.
A second area of focus lies in boosting education and awareness about clinical trials and research in communities through trusted intermediaries, such as churches.
Rounding out Lilly’s three-pronged work to reimagine clinical trials is the pharma’s push for community paradigms.
“We're committed to continue to drive that community-orientated/community-based research paradigm as a way of reaching more diverse patients,” Metcalf said.
This research setup is designed to bring clinical trials to the patient—the inverse of the historical single-site trial design. The community model features remote visits and assessments, and it builds on technological advances like wearable tech and AI to better understand patient demographics and more conveniently fit into an individual’s lifestyle.
“We’ve got some things we need to do to advance that view. A lot of it starts with sponsors being willing to take that on and make it a key,” Metcalf said, adding that the FDA’s public workshop is a space he’ll use to educate and promote the paradigm.
Metcalf is now working to educate the industry about the community-based trials, noting that further efforts from the FDA, healthcare systems and trial sponsors are necessary to move the paradigm forward.
“I don’t think there’s one element that will be ‘here’s the golden thread,’” Metcalf concluded. “I think it will be a grassroots effort.”