Speakers
Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine
Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute
Kevin Weinfurt, PhD
Professor and Vice Chair of Research
Department of Population Health Sciences
Duke University School of Medicine
Topic
NIH Collaboratory: Looking Back, Looking Forward
Keywords
Embedded pragmatic clinical trials; ePCTs; NIH Collaboratory; Health care systems research; NIH Collaboratory Trials; Living Textbook; HEAL Initiative; Coordinating Center; Research dissemination; Learning health systems; Real-world evidence
Key Points
- The NIH Collaboratory program provides a vantage point for the transformation of embedded clinical research.
- Currently, the Collaboratory supports 15 active embedded PCT NIH Collaboratory Trials.
- The Collaboratory was recently selected to serve as the Resource Coordinating Center for 4 new Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) as part of the NIH HEAL Initiative. These NIH Collaboratory Trials are pragmatic clinical trials aimed at improving availability of, effectiveness of, and adherence to evidence-based, nonpharmacologic pain management.
Discussion Themes
How can we harmonize the different ideas about what it is to be “pragmatic” for NIH study sections, IRBs, and DSMB reviews? For example, if your DSMB isn’t knowledgeable about PCTs, you could end up with a very explanatory trial.
A willingness to share imperfections is an important part of learning and helps the clinical trial ecosystem evolve.
An important future topic would be how the NIH Collaboratory and PCORnet fit together.
Read more about the NIH Collaboratory Program and the Living Textbook of Pragmatic Clinical Trials.
Tags
#pctGR, #PragmaticTrials, @Collaboratory1, @texhern, @lmhcurtis, @KevinWeinfurt