Reference number: OPUSeJ 201301141427SPR
Title: SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Authors: An-Wen Chan*, Phelan scientist 1, Jennifer M Tetzlaff, research coordinator 2, Peter C Gøtzsche, professor and director 3, Douglas G Altman, professor and director 4, Howard Mann, programme associate 5, Jesse A Berlin, vice president, epidemiology 6, Kay Dickersin, professor and director 7, Asbjørn Hróbjartsson, senior researcher 3, Kenneth F Schulz, distinguished scientist 8, Wendy R Parulekar, associate professor 9, Karmela Krleža-Jerić, adjunct professor10, Andreas Laupacis, professor 11, and David Moher, senior scientist 2,10.
Abstract: High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.
This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org).
The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
Author bio: N/A
Sponsor editor: N/A
1 Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8
2 Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
3 Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
4 Centre for Statistics in Medicine, University of Oxford, Oxford, UK
5 Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA
6 Janssen Research and Development, Titusville, USA
7 Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA
8 Quantitative Sciences, FHI 360, Research Triangle Park, USA
9 NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada
10 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
11 Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada
*Corresponding author: A-W Chan; firstname.lastname@example.org
Keywords: terms; separated; by; semi-colons N/A
Subject: Science/clinical trials; Medicine/ clinical trials
Bibliography: alphabetical N/A
Citation: Chan, A W, et al, 2013, “SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials”, BMJ 346: e7586. Published online 2013 January 9. doi: 10.1136/bmj.e7586. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3541470/.