Trial Registration and Declaration of Registration by Authors of Randomized Controlled Trials

Richard McGee · Michael Z. Su · Patrick John Kelly · Gail Y. Higgins · Jonathan C. Craig · Angela Claire Webster

34 citations0/0 files storedTransplantation

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

Abstract

BACKGROUND: Trial registration was introduced to reduce research bias by promoting trial transparency and accountability. We aimed to evaluate the frequency of, and factors associated with, trial registration and declaration of trial registration. METHODS: We selected all randomized controlled trials in kidney transplantation published between October 2005 and December 2010 and determined whether a trial was registered and whether a trial declared their registration in subsequent trial reports. RESULTS: Of 307 eligible trials identified, 24% (74/307) were registered, and of those, 59% (44/74) contained trial registration details within at least one trial report. Trial registration was more likely for trials published more than once, in later years or reported in journals that followed the International Committee of Medical Journal Editors guidelines. Trial registration was less likely for trials that did not declare their funding sources. Registered trials were more likely to declare registration details in related reports if published in later years or in a journal that followed International Committee of Medical Journal Editors guidelines. Trials that did not declare their funding sources were less likely to declare registration details. CONCLUSIONS: Although still suboptimal, the situation is improving over time, with both trial registration and declaration of registration details more likely in later years.

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References

2010Dissemination and publication of research findings: an updated review of related biases 1986Publication bias: the case for an international registry of clinical trials.2009Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials 1987Publication bias and clinical trials 2010How to write a Cochrane systematic review 2005Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)2011Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists 2010Influence of trial registration on reporting quality of randomized trials: Study from highest ranked journals

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