Center for Medical Ethics and Health Policy Staff Publications
Language
English
Publication Date
7-1-2024
Journal
Learning Health Systems
DOI
10.1002/lrh2.10413
PMID
39036536
PMCID
PMC11257052
PubMedCentral® Posted Date
3-6-2024
PubMedCentral® Full Text Version
Post-print
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.
Keywords
post‐trial access, post‐trial obligations, pragmatic clinical trials, research ethics
Published Open-Access
yes
Recommended Citation
Morain, Stephanie R; O'Rourke, P Pearl; Ali, Joseph; et al., "Post-Trial Responsibilities in Pragmatic Clinical Trials: Fulfilling the Promise of Research To Drive Real-World Change" (2024). Center for Medical Ethics and Health Policy Staff Publications. 322.
https://digitalcommons.library.tmc.edu/med_ethics/322