Thought leaders came together for the second track of the ACRP 2020 Virtual Conference in late April to survey a clinical trial landscape reeling from the COVID-19 pandemic and changing at a dizzying pace.
“It’s ironic, but this negative disruption is propelling vision and innovation” as clinical trial practitioners reexamine how and why they do what they do, Leanne Madre, JD, MHA, director of strategy with the Clinical Trials Transformation Initiative, told attendees.
“The clinical trials of last year are not the clinical trials of next year,” said Karen Lindsley, DNP, RN, CCRC, CDE, a manager with the Georgia Clinical and Translational Science Alliance at Emory University’s School of Medicine.
Where polls found more than 50% of the American population was unaware of the existence of clinical trials pre-COVID-19, that’s certainly changed today, Lindsley said. “Clinical trials have upped their face value,” she added.
The need for study team members with enhanced research competencies is radically increasing in the new clinical trial landscape, Lindsley said. She advised learners to pick continuing education opportunities that “stretch you” and make you a stronger and more valuable performer. Leverage ACRP’s competencies roadmap “for yourself and your team” to identify skill gaps to plug, she suggested.
“ACRP is a leader in thinking about workforce development,” Madre added.
Experts shared additional insights over four sessions. Highlights included:
- If data aren’t “ethically clean, [they] can be skewed with political” or other dangerous bias, warned Lindsley. Tech giants Apple, Amazon, and Google are “driving centralized trial ecosystems” in ways unimaginable just a few years ago, she added.
- Used skillfully, digital twins can “allow for projections under different scenarios” with fewer actual patients required, said Charles Fisher, PhD, founder and CEO of Unlearn AI. “Digital twins allow you to make use of all the data” and fuel better decisions, he noted. Digital twins can also provide a “matched control for each patient,” Fisher said.
- When considering an SAAS system, think not just about today’s requirements, but what you may need in the next two to five years, said Leigh Burgess, MHA, MEd, MA, vice president for research operations at Dartmouth-Hitchcock Health. Don’t get too hung up on customization when exploring SAAS, she said. Early in the process, Burgess clung too tightly to idea that if she wasn’t asking for customizations “it wouldn’t be ours.” In fact, she found, customization is rarely needed and should be vetted carefully before going in that direction. Burgess also stressed the importance of getting everyone onboard as early in the change management process as possible. “Decisions should be driven by the people actually doing the work,” she noted.
The ACRP 2020 Virtual Conference resumes May 14 with sessions on study management and conduct.
Author: Michael Causey