The technological bells and whistles garner the lion’s share of attention, but it’s good old-fashioned leadership that lays the foundation of successful innovation. “Technology is great, but we have a tendency to over evangelize its benefits” and forget people will ultimately determine whether a project attains its goals, says Adam Samson, MS, RD, PMP, CCRA, CCRC, senior director of clinical operations and customer success for Curebase.
Technology can significantly enhance clinical trial productivity and reach, “but it can get messy” if it’s not handled properly before, during, and after implementation, Samson says. For example, “there’s been a ton of talk about the technology” aspects of decentralized clinical trials (DCTs), “but not enough talk about getting people ready” with leadership, training, and other necessary tools, he notes.
Research sites are being asked to adapt to a lot of change these days, Samson says, and it’s important for leaders to recognize how jarring the past few years have been for clinical trial research professionals. “Research sites went from one day overseeing everything centrally, to over a short period of time (as the COVID-19 pandemic began impacting operations), trying to do the same things remotely,” he says. “They were still overseeing trials, but their colleagues were no longer down the hall.”
It’s a brave new world for everyone, especially principal investigators (PIs), Samson adds. He’s a big advocate of keeping PIs more closely engaged in trials by, among other things, having a trained professional handle meeting minutes at frequent gatherings either in-person or remotely. The note taker should be more than a robotic court stenographer, he says.
Oversight from a Distance: How to Set Site Leadership Up for Success in Virtual and Hybrid Trials
Join Samson at ACRP 2022 as he presents best practices for ensuring effective site-level management of fully virtual or hybrid trials. Samson will share his experiences conducting 20+ decentralized trials across multiple indications while offering practical resources to help with PI oversight, regulatory compliance, and much more.
Done effectively, the meeting minutes can be used to “demonstrate adequate oversight” to trial personnel and inspectors at the U.S. Food and Drug Administration (FDA), Samson notes. “Meeting minutes can also help identify areas where the trial might need additional support,” he adds. “Meeting minutes can help set clear expectations” throughout the trial, and ensure follow-up as required.The person who takes the meeting minutes should be “an active participant” in the trial who can recognize and isolate decisions made, and highlight action items raised during meetings, Samson says. “I’m a big advocate of training, and the person who keeps the meeting minutes” deserves training and access to necessary tools, he notes.
“Smart people can figure out how to write useful meeting minutes on their own, but we should help in any way we can with existing templates and best practices,” Samson says.
Author: Michael Causey