Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems

Clinical Trials : Journal of the Society for Clinical Trials
Monique L Andersonparticipants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop

Abstract

Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these typ...Continue Reading

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Citations

Nov 2, 2016·AJOB Empirical Bioethics·Kevin P WeinfurtJeremy Sugarman
Nov 12, 2016·AJOB Empirical Bioethics·Ashley KraybillScott D Halpern
Jun 15, 2016·Health Research Policy and Systems·Ansgar GerhardusEva Hummers-Pradier
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Clinical Trials Mentioned

NCT02015455
NCT01888146
NCT02063867
NCT01742065
NCT02019225

Software Mentioned

ABATE

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