Though the plan was in the works before COVID-19 hit, Amir Kalali, MD, says the pandemic has only made the need for his new Decentralized Trials & Research Alliance (DTRA) all the more apparent. “We felt there was a need for this before the pandemic,” said Kalali, a life science executive, founder of several collaborative life science communities, and co-convener of DTRA.
“Before the pandemic there was only incremental usage” of decentralized trial tools, said Craig Lipset, DTRA co-convener, clinical innovation advisor, and a pioneer in decentralized trials. “We want to help break the barrier and encourage meaningful adoption of decentralized trials where appropriate,” he added.
Specifically, the DTRA is a broad alliance of 50-and-counting life sciences and healthcare organizations seeking to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The Alliance plans to unite stakeholders, including healthcare companies, regulators, patient groups, and research organizations, with a mission to make clinical trial participation widely accessible by advancing policies, research practices, and new technologies in decentralized clinical research.
“We’ve had more than 100 additional inquiries about joining since we announced DTRA,” Kalali said.
Experts estimate that COVID-19 may set back non-pandemic clinical trials by several years due to prospective patients’ inability or reluctance to schedule visits at physical research locations. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators, DTRA advocates believe.
Further, inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge. COVID-19 has amplified the disparities and inclusion biases that have become hurdles for potential trial participants, most experts agree.
DTRA’s leadership council met earlier in December to ratify priorities and commit to beginning several workstreams in 2021, Lipset said. “DTRA will be a clearinghouse” and springboard for sharing best practices, he added.
DTRA member organizations will provide expertise to identify and address gaps and needs, and to advance best practices through effective education and communication. Organizations interested in taking part can visit DTRA.org.
Author: Michael Causey