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Sounding Board

Randomized Clinical Trials — Removing Unnecessary Obstacles

List of authors.
  • Christina Reith, M.B., Ch.B.,
  • Martin Landray, M.B., Ch.B.,
  • P.J. Devereaux, M.D., Ph.D.,
  • Jackie Bosch, M.Sc.,
  • Christopher B. Granger, M.D.,
  • Colin Baigent, B.M., B.Ch.,
  • Robert M. Califf, M.D.,
  • Rory Collins, M.B., B.S.,
  • and Salim Yusuf, M.D., D.Phil.

The authors, who are experienced clinical trialists, propose a framework for expediting the conduct of clinical trials and reducing what they perceive as unnecessary bureaucracy in current trial regulations.

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Funding and Disclosures

All authors are members of the Sensible Guidelines Group, which is organized jointly by the Population Health Research Institute, Hamilton Health Sciences and McMaster University; the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford; and the Duke Clinical Research Institute, Duke University.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Author Affiliations

From the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (C.R., M.L., C.B., R.C.); the Population Health Research Institute, Hamilton Health Sciences and McMaster University — both in Hamilton, ON, Canada (P.J.D., J.B., S.Y.); and the Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G., R.M.C.).

Address reprint requests to Dr. Reith at the Clinical Trial Service Unit and Epidemiological Studies Unit, Richard Doll Bldg., Old Road Campus, Roosevelt Dr., Oxford OX3 7LF, United Kingdom, or at .

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