Availability of study protocols for randomized trials published in high-impact medical journals: A cross-sectional analysis

O’Mareen Spence · Kyungwan Hong · Richie Onwuchekwa Uba · Peter Doshi

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Meta-analysis and systematic reviews Academic Publishing and Open Access Pharmaceutical industry and healthcare

Abstract

Background: To improve reporting transparency and research integrity, some journals have begun publishing study protocols and statistical analysis plans alongside trial publications. We sought to assess the overall availability and characteristics of protocols and statistical analysis plans of randomized clinical trials published in the top five (by impact factor) general medicine journals. Methods: All randomized clinical trials published in Annals of Internal Medicine, BMJ, JAMA, Lancet, and NEJM in 2016 were identified. For each randomized clinical trial, we searched for protocols and statistical analysis plans on journal websites (including supplementary material) and in the article, for example, a referenced publication or link to trial or institutional website. Characteristics of randomized clinical trials were extracted from the publication and clinical trial registry. A detailed assessment of protocols and statistical analysis plans was conducted in a 20% random sample of randomized clinical trials. Results: Protocols were available for 299 (82%) trials, ranging from 50% in BMJ to >95% in NEJM and JAMA. Statistical analysis plans were available for 182 (50%) trials and varied from <10% for Annals of Internal Medicine, BMJ, and Lancet to 92% for NEJM. Of the 76 randomized clinical trials in the 20% random sample, 63 (83%) had a protocol but less than half (31; 44%) included an a priori (dated prior to patient enrollment) version of the protocol. Statistical analysis plans were available for 35 (46%) trials, and only 5 (7%) included an a priori version. Conclusion: Protocols and statistical analysis plans are publicly available for the majority of trials. However, the a priori versions of these documents are only available for a minority of trials. More attention must be paid to ensuring the public availability of a priori versions.

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References

2004Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials 2004Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research 2011Comparison of protocols and registry entries to published reports for randomised controlled trials 2017Update on Trial Registration 11 Years after the ICMJE Policy Was Established 2015Comparison of registered and published outcomes in randomized controlled trials: a systematic review 2019COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time 2018How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider 2014Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials

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