In a new episode of the Rethinking Clinical Trials Podcast, Emily O’Brien of Duke University expanded on key takeaways from her recent Grand Rounds presentation, “Avoiding the Fumble: Building on a Decade of Lessons from Pragmatic Clinical Trials.”

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The Grand Rounds presentation came on the heels of a big decade for pragmatic clinical trials, defined by new opportunities and challenges.

“We’ve seen a huge explosion in interest,” said O’Brien. “And that often comes some reality checks as people begin to understand what it takes to do one of these studies well across multiple sites.”

“The concept of the fumble has been an interesting way to acknowledge that we don’t always get things perfectly right the first time.”

O’Brien and her colleagues on the PCORnet^® team developed “The Playbook” as a tool for sharing and refining the best approach to national-scale research. It is a pragmatic application of principles often discussed within the NIH Collaboratory, providing investigators with practical strategies for implementation.

Like the Living Textbook, the Playbook is a living document that will be updated to reflect learnings from the successes and fumbles of future trials.

“If we can establish a culture of transparency and sharing, that can accelerate the implementation of best practices and refinement of those practices,” O’Brien said.

O’Brien is an associate professor in population health sciences at Duke University. She serves as cochair of the NIH Collaboratory’s Patient-Centered Outcomes Core Working Group.