TY - JOUR
T1 - Exploring the ethical and regulatory issues in pragmatic clinical trials
AU - Califf, Robert M.
AU - Sugarman, Jeremy
N1 - Funding Information:
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. Additional support was provided by the Patient-Centered Outcomes Research Institute (PCORI) Award for development of the National Patient-Centered Clinical Research Network (PCORnet). The views presented here are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee, or other participants in PCORnet.
Funding Information:
Dr Sugarman receives grant support from the National Institutes of Health and the Patient-Centered Outcomes Research Institute and consulting income from Merck KGaA.
Publisher Copyright:
© 2015 The Society for Clinical Trials.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care.
AB - The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care.
KW - Clinical trials
KW - cluster-randomized trial
KW - ethics
KW - evidence-based medicine
KW - learning health-care system
KW - patient-centered outcomes research
KW - pragmatic clinical trial
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U2 - 10.1177/1740774515598334
DO - 10.1177/1740774515598334
M3 - Article
C2 - 26374676
AN - SCOPUS:84942932829
SN - 1740-7745
VL - 12
SP - 436
EP - 441
JO - Clinical Trials
JF - Clinical Trials
IS - 5
ER -