Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change

Abstract

While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings—or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post-trial responsibilities, and then identify challenges for post-trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision-makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real-world practice.

Department

Description

Provenance

Citation

Published Version (Please cite this version)

10.1002/lrh2.10413

Publication Info

Morain, Stephanie R, P Pearl O'Rourke, Joseph Ali, Vasiliki Rahimzadeh, Devon K Check, Hayden B Bosworth and Jeremy Sugarman (2024). Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change. Learning Health Systems. 10.1002/lrh2.10413 Retrieved from https://hdl.handle.net/10161/31222.

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Scholars@Duke

Check

Devon Karnes Check

Assistant Professor in Population Health Sciences

Devon Check, PhD is a health services and implementation researcher whose primary research interests include quality of care and the implementation of evidence-based and guideline-recommended practices in oncology. Her projects use large secondary data analysis as well as qualitative and mixed methods to investigate variation and inequities in cancer care, the experiences of patients and clinicians, and multi-level factors that impact cancer treatment and outcomes. She has a specific interest in supportive cancer care, and within that area, she has a growing portfolio of research projects focused on pain and symptom management in cancer. 

Dr. Check also has methodological expertise in implementation science. She has served as the implementation research methods expert on several behavioral intervention trials that use a hybrid effectiveness-implementation design. She also co-leads the Implementation Science Core Working Group as part of the Coordinating Center for the NIH Pragmatic Trials Collaboratory and the NIH HEAL Collaboratory. 

Dr. Check received her PhD in Health Policy and Management from the Gillings School of Global Public Health at UNC-Chapel Hill. Prior to joining the Department of Population Health Sciences at Duke, she completed a postdoctoral fellowship in Delivery Science at Kaiser Permanente Northern California's Division of Research. 

Areas of Expertise: Implementation Science and Health Services Research

Bosworth

Hayden Barry Bosworth

Professor in Population Health Sciences

Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)  at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities. 

Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.

Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy


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