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Exploring the ethical and regulatory issues in pragmatic clinical trials

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 informat... Full description

Journal Title: Clinical trials (London England), 2015-10, Vol.12 (5), p.436-441
Main Author: Califf, Robert M
Other Authors: Sugarman, Jeremy
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: London, England: SAGE Publications
ID: ISSN: 1740-7745
Link: https://www.ncbi.nlm.nih.gov/pubmed/26374676
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4891194
title: Exploring the ethical and regulatory issues in pragmatic clinical trials
format: Article
creator:
  • Califf, Robert M
  • Sugarman, Jeremy
subjects:
  • Article
  • Biomedical Research - ethics
  • Biomedical Research - legislation & jurisprudence
  • Biomedical Research - standards
  • Clinical trials
  • Clinical Trials as Topic - ethics
  • Clinical Trials as Topic - legislation & jurisprudence
  • Clinical Trials as Topic - standards
  • Cluster randomized trial
  • Decision Making - ethics
  • Ethics
  • Evidence-based medicine
  • Humans
  • Learning healthcare system
  • Medical ethics
  • National Institutes of Health (U.S.)
  • Patient-centered outcomes research
  • Pragmatic clinical trial
  • Research Design - standards
  • Surveys and Questionnaires
  • United States
ispartof: Clinical trials (London, England), 2015-10, Vol.12 (5), p.436-441
description: 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.
language: eng
source:
identifier: ISSN: 1740-7745
fulltext: no_fulltext
issn:
  • 1740-7745
  • 1740-7753
url: Link


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descriptionThe 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.
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notesDr. Califf is currently Deputy Director for Medical Products and Tobacco, U.S. Food and Drug Administration, Rockville, Maryland.
abstractThe 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.
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