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Am Heart J2024;27562-73.September 1, 2024Journal Article

Framework of the strengths and challenges of clinically integrated trials: An expert panel report.

Anthony E Peters1, W Schuyler Jones2, Brian Anderson3, Carolyn T Bramante4, Uli Broedl5, Christoph P Hornik6, Lindsay Kehoe7, Kirk U Knowlton8, Esther Krofah9, Martin Landray10, Trevan Locke11, Manesh R Patel2, Mitchell Psotka12, Frank W Rockhold13, Lothar Roessig14, Russell L Rothman15, Lesley Schofield16, Norman Stockbridge17, Anne Trontell18, Lesley H Curtis7, Pamela Tenaerts19, Adrian F Hernandez20
1Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.
2Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
3MITRE, Bedford, MA.
4Departmentd of Medicine, University of Minnesota Medical School, Minneapolis, MN.
5Boehringer Ingelheim, Ridgefield, CT.
6Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Pediatrics, Duke University School of Medicine, Durham, NC.
7Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
8Intermountain Medical Center Heart Institute, Salt Lake City, UT.
9Milken Institute, Washington, DC.
10University of Oxford, Oxford, England.
11Margolis Institute for Health Policy, Duke University, Durham, NC.
12Inova Heart and Vascular Institute, Falls Church, VA.
13Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, NC.
14Bayer AG, Wuppertal, Germany.
15Vanderbilt University Medical Center, Nashville, TN.
16Novartis Pharmaceuticals Corporation, East Hanover, NJ.
17Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
18Patient-Centered Outcomes Research Institute (PCORI), Washington, DC.
19Medable, Palo Alto, CA.
20Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: Adrian.hernandez@duke.edu.
PubMed PMC DOI PDF

Abstract

The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate…

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