TY - JOUR
T1 - Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems
AU - Anderson, Monique L.
AU - Califf, Robert M.
AU - Sugarman, Jeremy
N1 - Funding Information:
Dr Anderson receives grant support from the National Institutes of Health. Dr Califf receives grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the US Food and Drug Administration, the Clinical Trials Transformation Initiative, Merck, Roche, Aterovax, Bayer, Janssen Pharmaceuticals, Eli Lilly & Company, and Schering-Plough; grants and personal fees from Novartis, Amylin, Scios, and Bristol-Myers Squibb/Bristol-Myers Squibb Foundation; and personal fees from WebMD, Kowa Research Institute, Nile, Parkview, Orexigen, Pozen, Servier International, Bayer Healthcare, Bayer Pharma AG, CV Sight, Daiichi Sankyo/Lilly, Gambro, Gilead, Heart.org –Bayer, Medscape, Pfizer, Regeneron, TMC, GlaxoSmithKline, Genentech, Heart.org–Daiichi Sankyo, and Amgen. Dr Califf also holds equity in Nitrox/N30 and Portola. A full listing of disclosure information for Dr. Califf is available at https://www.dcri.org/about-us/conflict-of-interest . Dr Sugarman receives grant support from the National Institutes of Health and the Patient-Centered Outcomes Research Institute and consulting income from Merck KGaA. This work was supported by the National Institutes of Health (NIH) Common Fund, through a cooperative agreement (U54 AT007748) from the Office of Strategic Coordination within the Office of the NIH Director.
Publisher Copyright:
© The Author(s) 2015.
PY - 2015/6/11
Y1 - 2015/6/11
N2 - 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.
AB - 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.
KW - Ethics
KW - clinical trials
KW - cluster randomized trials
KW - pragmatic clinical trials
KW - regulations
UR - http://www.scopus.com/inward/record.url?scp=84929164648&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84929164648&partnerID=8YFLogxK
U2 - 10.1177/1740774515571140
DO - 10.1177/1740774515571140
M3 - Article
C2 - 25733677
AN - SCOPUS:84929164648
VL - 12
SP - 276
EP - 286
JO - Clinical Trials
JF - Clinical Trials
SN - 1740-7745
IS - 3
ER -