As it enthusiastically embraces aspects of decentralized clinical trials (DCTs), the drug and device development industry is running the risk of “leapfrogging over [study] sites and forgetting about them as a key stakeholder” in the enterprise, says Mary Costello, head of the site and investigator network for Medable.
“We have to be careful or we’re going to disenfranchise a key component” by failing to include sites early and often in DCT implementation plans, Costello notes. “We’re getting a little too futuristic and maybe not grounded in reality by forgetting about the important role of sites and the human connection” in successful clinical trials, she adds.
Medable has recently launched a Site Network Council (SNC) designed to, among other things, ensure the voice of the sites is heard loud and clear as industry grapples with the DCT transition, Costello says.
“We need to add the human touch to clinical research,” and that includes engaging sites and helping them retain patients throughout DCTs, says SNC member Sarah Grover, a site qualification specialist at Elligo Health Research. She’s also a big proponent of promoting “diversity in all forms, including racial and different perspectives” in trial conduct and design.
“We don’t want take the humanity out of trials,” agrees Costello. She’s a firm believer in the ongoing role of sites and brick and mortar locations as industry moves toward increased usage of DCTs and hybrid trials embracing elements of both remote and onsite approaches.
The evolution to DCTs is akin to “crossing a chasm,” Costello says. “It doesn’t come easy, and it comes down to the human connection and engaging vastly different voices and communities.”
Grover is also a big advocate for increased workforce training to help usher in a successful era of increased DCT and hybrid trial usage. “Training must keep up with technology,” she says.
Costello advocates training for the same reason, but adds that high industry turnover rates also make it important to ensure a team stays at the forefront of research trends and best practices.
The SNC held its first meetings earlier this year and plans its next gathering for the end of October, Costello says.
Author: Michael Causey