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.
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.
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