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2015 ; 12
(3
): 276-86
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Ethical and regulatory issues of pragmatic cluster randomized trials in
contemporary health systems
#MMPMID25733677
Anderson ML
; Califf RM
; Sugarman J
Clin Trials
2015[Jun]; 12
(3
): 276-86
PMID25733677
show ga
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.