SPIRIT 2013: new guidance for content of clinical trial protocols
The LancetPublished 1 January 2013
An‐Wen Chan, Jennifer Tetzlaff, Douglas G. Altman, Kay Dickersin, David Moher
Citations329
SJR quartileQ1
SJR score12.11
SNIP22.72
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Abstract
The protocol is an important document that details the background, methods, ethical considerations, and administration of a clinical trial. 1 Chan A-W Tetzlaff JM Altman DG et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158 (in press). Crossref Scopus (3610) Google Scholar The information contained in the protocol is useful for several groups. For those involved in the trial, the protocol provides the information needed for the study to be implemented consistently across collaborators in a way that mirrors the intentions of the principal investigators. For external groups who review the trial, such as research ethics committees (REC), funders, regulators, journal editors, potential participants, health-care providers, and systematic reviewers, the protocol provides a window into the nature and quality of the study plans and subsequent amendments. The protocol also allows for an assessment of consistency between the final report and the original intent. 2 Dwan K Altman DG Cresswell L Blundell M Gamble CL Williamson PR Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011; 1: MR000031 PubMed Google Scholar
Keywords
Decision SciencesMedicine
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