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      SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

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          Abstract

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.

          The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

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          Author and article information

          Journal
          0372351
          596
          Ann Intern Med
          Ann. Intern. Med.
          Annals of internal medicine
          0003-4819
          1539-3704
          8 November 2016
          05 February 2013
          17 November 2016
          : 158
          : 3
          : 200-207
          Affiliations
          Women’s College Research Institute, Women’s College Hospital, and Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada; Ottawa Methods Centre, Ottawa Hospital Research Institute, Ethics Office, Canadian Institutes of Health Research, and University of Ottawa, Ottawa, Ontario, Canada; Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom; Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark; University of Utah School of Medicine, Salt Lake City, Utah; Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, New Jersey; UK Medical Research Council Clinical Trials Unit, The Lancet, and BMJ, London, United Kingdom; NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Ontario, Canada; Quantitative Sciences, FHI 360, and GlaxoSmithKline, Research Triangle Park, North Carolina; The Dartmouth Institute for Health Policy and Clinical Practice, The Geisel School of Medicine at Dartmouth, Hanover, New Hampshire; The PR Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, California
          Author notes
          Requests for Single Reprints: An-Wen Chan, MD, DPhil, Women’s College Research Institute, Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada; anwen.chan@ 123456utoronto.ca

          Current Author Addresses: Dr. Chan: Women’s College Research Institute, Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada.

          Ms. Tetzlaff: Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.

          Dr. Altman: Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford OX2 6UD, United Kingdom.

          Dr. Laupacis: Keenan Research Centre at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.

          Drs. Gøtzsche and Hróbjartsson: Nordic Cochrane Centre, Rigshospitalet Department 3343, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark.

          Dr. Krleža-Jerić: Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario K1H 8M5, Canada.

          Dr. Mann: Division of Medical Ethics and Humanities, University of Utah School of Medicine, 75 South 2000 East #108, Salt Lake City, UT 84132.

          Dr. Dickersin: Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Mail Room W5010, Baltimore, MD 21205.

          Dr. Berlin: Janssen Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson, 1125 Trenton Harbourton Road, Titusville, NJ 08560.

          Ms. Doré: UK Medical Research Council Clinical Trials Unit, 125 Kingsway, London WC2B 6NH, United Kingdom.

          Dr. Parulekar: NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, 10 Stuart Street, Kingston, Ontario K7L 3N6, Canada.

          Dr. Summerskill: The Lancet, 32 Jamestown Road, London NW1 7BY, United Kingdom.

          Dr. Groves: BMJ, BMA House, Tavistock Square, London WC1H 9JP, United Kingdom.

          Dr. Schulz: Quantitative Sciences, FHI 360, Research Triangle Park, 2224 East NC Highway 54, Durham, NC 27713.

          Dr. Sox: The Dartmouth Institute for Health Policy and Clinical Practice, The Geisel School of Medicine at Dartmouth, HB 7500, Hanover, NH 03755.

          Dr. Rockhold: GlaxoSmithKline, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC 27709.

          Dr. Rennie: The Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, 3333 California Street, Laurel Heights 265, San Francisco, CA 94143-0936.

          Dr. Moher: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.

          Article
          PMC5114123 PMC5114123 5114123 capmc6040
          10.7326/0003-4819-158-3-201302050-00583
          5114123
          23295957
          f0e83f5e-aaf2-4b7f-9ff4-117fb8d164df
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