TY - JOUR
T1 - SPIRIT 2013 Statement
T2 - Defining Standard Protocol Items for Clinical Trials
AU - Chan, An-Wen
AU - Tetzlaff, Jennifer M
AU - Altman, Douglas G
AU - Laupacis, Andreas
AU - Gøtzsche, Peter C
AU - Krleža-Jerić, Karmela
AU - Hróbjartsson, Asbjørn
AU - Mann, Howard
AU - Dickersin, Kay
AU - Berlin, Jesse A
AU - Doré, Caroline J
AU - Parulekar, Wendy R
AU - Summerskill, William S M
AU - Groves, Trish
AU - Schulz, Kenneth F
AU - Sox, Harold C
AU - Rockhold, Frank W
AU - Rennie, Drummond
AU - Moher, David
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
U2 - 10.7326/0003-4819-158-3-201302050-00583
DO - 10.7326/0003-4819-158-3-201302050-00583
M3 - Journal article
C2 - 23295957
SN - 0003-4819
VL - 158
SP - 200
EP - 207
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 3
ER -