SPIRIT 2013 Statement just published

Published on 8 January 2013 in both the BMJ and Annals of Internal Medicine, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides guidance regarding the minimum content that should be included in a clinical trial protocol. A 33-item checklist and diagram are provided with the aim of  helping to ensure that published trial protocols are of a high quality.

An explanatory paper (SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials) has also been published discussing the rationale and supporting evidence for each checklist item and providing examples from actual protocols.

References

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207.PMID: 23295957

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586. PMID: 23303884

A comment about SPIRIT 2013 has also been published in the Lancet.

SPIRIT website

The SPIRIT website is available at: http://www.spirit-statement.org/