Leaders of 2 of the NIH Pragmatic Trials Collaboratory’s long-standing Core Working Groups recently shared updates from their work with the newest cohort of NIH Collaboratory Trials. We spoke with them during the NIH Collaboratory’s 2024 Annual Steering Committee Meeting in May.
Over the last year, the Ethics and Regulatory Core engaged in a formal onboarding process with the program’s 9 newest pragmatic trials, consulting with the investigators about their trial planning and implementation. Cochairs Stephanie Morain and Pearl O’Rourke summarized several of the ongoing and emerging challenges.
“One of the challenges we’re continuing to see is understanding what are the appropriate duties that institutions and investigators have in the context of a [pragmatic clinical trial],” said Morain. “One concrete area is in data and safety monitoring. What kinds of issues need to be monitored as adverse events? How do we think about them as being related to the trial vs relating to the background care?” she added.
Onboarding documentation from the Ethics and Regulatory Core’s consultations with the NIH Collaboratory Trials is available on our Data and Resource Sharing page.
We also spoke with Liz Turner and Patrick Heagerty, cochairs of the Biostatistics and Study Design Core. They have spent the past year advising the NIH Collaboratory Trial investigators on key study design challenges.
“Many of these studies have individually randomized patients but then they’re studying implementation pathways when they implement through a specific person that puts them in groups—these are individually randomized group treatment trials,” said Heagerty. “Several of the studies didn’t see that, and so we helped them see it and we helped them work through how to adapt their analysis and modify their sample size work to ensure the trial was properly sized,” he explained.
In addition to consultations with the NIH Collaboratory Trials, the Biostatistics and Study Design Core continues to develop and innovate pragmatic trials methodology.