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

Published

Journal Article

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 types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.

Full Text

Duke Authors

Cited Authors

  • Anderson, ML; Califf, RM; Sugarman, J; participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop,

Published Date

  • June 2015

Published In

Volume / Issue

  • 12 / 3

Start / End Page

  • 276 - 286

PubMed ID

  • 25733677

Pubmed Central ID

  • 25733677

Electronic International Standard Serial Number (EISSN)

  • 1740-7753

International Standard Serial Number (ISSN)

  • 1740-7745

Digital Object Identifier (DOI)

  • 10.1177/1740774515571140

Language

  • eng