Public availability of trial protocols

The Lancet has improved efforts to reduce research waste and increase the importance of scientific contributions through the Reward Campaign. One of the targets of this campaign is to make the methods of studies more accessible, which could be accomplished by increasing the public availability of research protocols. A protocol is a document that describes the aims, interventions, outcomes, statistical procedures, ethical considerations, and planned use and dissemination of data before the start of a clinical trial. 1 Chan A-W Tetzlaff JM Gøtzsche PC et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013; 346: 7586 Crossref PubMed Scopus (2407) Google Scholar Protocols help safeguard against unethical changes in methods and reporting of the trial and are important tools for research quality control, integrity, and transparency. 2 The LancetStrengthening the credibility of clinical research. Lancet. 2010; 375: 1225 Summary Full Text Full Text PDF PubMed Scopus (21) Google Scholar Despite their importance, there is little literature describing the availability and accessibility of protocols (a PubMed search of "protocol availability" did not uncover any relevant literature). There are open-access (OA) journals that encourage the submission and publication of protocols, such as BMJ Open, JMIR Research Protocols, and Trials. The SPIRIT guideline 3 Chan A-W Tetzlaff JM Altman DG et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158: 200-207 Crossref PubMed Scopus (3098) Google Scholar is a checklist for items that should be included in a research protocol but does not discuss the importance of public availability of protocols. Investigators may not, therefore, be motivated to submit their protocols for publication in journals or to share them on websites or registries. Department of ErrorLucey M, Clark J, Glasziou P. Public availability of trial protocols. Lancet 2017; 390: e54–55. In this Comment, PG should not have been listed as a founding member of SPIRIT in the competing interests statement. This correction has been made to the online version as of March 22, 2018. Full-Text PDF SPIRIT promotes protocol sharingIn a Comment examining the clinical trial manuscripts submitted to The Lancet and The Lancet Psychiatry, Morgan Lucey and colleagues1 found that the study protocol was publicly available for only a third of trials. This paucity of protocol sharing is problematic because other sources of information on trial design and conduct are usually less detailed and might not accurately reflect the protocol.2 As founders of the SPIRIT initiative on protocol content,3,4 we wish to emphasise that, contrary to the assertions by Lucey and colleagues, SPIRIT strongly advocates protocol sharing and recommends that protocol authors include a specific statement about protocol and data availability so that these important issues are considered during the planning of a trial. Full-Text PDF