Clinical Trial Leaders Stress Cooperation, Innovation to Spur Improvement

Cristin MacDonald, PhD, Vice President, Client Delivery, The Avoca Group

“To drive change, it takes all stakeholders understanding the challenges of the others,” Association of Clinical Research Professionals (ACRP) Executive Director Jim Kremidas told attendees at part one of the ACRP – Avoca Quality Congress yesterday (September 10). “COVID-19 is forcing us to use decentralized clinical trials (DCTs), and that’s a silver lining [because] it’s generating momentum we should all be excited about” to modernize and advance clinical trial quality and outcomes, he said.

“COVID has been the disruptor,” agreed Cristin MacDonald, vice president for client delivery at The Avoca Group. The pandemic “has really created a situation where new technologies and ideas had to [suddenly] be used in order to keep trials going. It’s caused an abrupt shift to virtualization, and it’ll be interesting to see if it continues” after the pandemic subsides, she added.

“COVID has opened our eyes to new ways of doing things,” said Andy Lee, senior vice president and head of global clinical trial operations at Merck. By being open to new technologies and practices, Merck has “stayed open for business” conducting trials throughout the pandemic, Lee added.

MacDonald also talked about an anecdotal observation fueled by working closely over the past few months with many clinical trial professionals. “We’ve seen a decision-making shift [during COVID] where sites have become the focus of decision-making” in terms of risk assessments and other trial operational choices, she said.

Stressing the importance of finding industry-wide agreement on terms like DCT and hybrid trials, ACRP Workforce Innovation Officer Beth Harper told attendees that, while technology was in the process of forever transforming the clinical trial landscape, the need for so-called soft skills has never been greater.

Going forward, clinical trial practitioners are going to have to discover new sources of “patience” when working to learn new technology, in part because sponsors have emphasized its importance to them in constructing the clinical trials of tomorrow, Harper said.

“As clinical research evolves, the successful professional will embrace change, be open to learning new technology and new processes, be flexible when there are obstacles, and be patient with others,” Harper added.

“We need new skills” in the future workforce, agreed Chris Frega, vice president and study operations head at Syneos Health. He specifically cited the need for soft skills and openness to technology.

Calling 2020 “the year of adoption,” Craig Lipset, managing partner of Clinical Innovation Partners, warned against making DCTs more complex than necessary. “We get lost when we talk about DCTs as something big and heavy,” he said. Instead, DCTs boil down to “a tool kit of methods, and the winners” will be the ones who figure out the right DCT tools to use at the right times, Lipset said.

“Now is the perfect time to ask and involve patients” in the development of trials to a greater degree, said Kristen Smedley, founder of the Curing Retinal Blindness Foundation.

Further, the clinical trial workforce should not fear technology, Lee said. Rather, trial practitioners should feel confident they will “play an important role” in any form of trial, and that’s a fact that’s “not going to go away,” regardless of how prevalent DCTs becomes, he said.

“Rather than being a threat to job roles, [technology] will generate the need for the evolution of existing roles and bring unprecedented flexibility and efficiency,” Harper added.

New roles likely to emerge include the technology trainer for contract research organizations, site technology support specialist, remote trial coordinator, decentralized investigator, and virtual patient guide, Harper said. “Technology and soft skills we be critical for success,” she stressed.

Part two of the ACRP – Avoca Quality Congress will be held Tuesday, September 15.

Author: Michael Causey