Abstract
BackgroundIt is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and relevant systematic review should be included. The aim of this study was to assess the use of the existing evidence in order to justify trial conduct.MethodsProtocols of randomised trials published over a 1-month period (December 2015) indexed in PubMed were obtained. Data on trial characteristics relating to location, design, funding, conflict of interest and type of evidence included for trial justification was extracted in duplicate and independently by two investigators. The frequency of citation of previous research including relevant systematic reviews and randomised trials was assessed.ResultsOverall, 101 protocols for RCTs were identified. Most proposed trials were parallel-group (n = 74; 73.3%). Reference to an earlier systematic review with additional randomised trials was found in 9.9% (n = 10) of protocols and without additional trials in 30.7% (n = 31), while reference was made to randomised trials in isolation in 21.8% (n = 22). Explicit justification for the proposed randomised trial on the basis of being the first to address the research question was made in 17.8% (n = 18) of protocols. A randomised controlled trial was not cited in 10.9% (95% CI: 5.6, 18.7) (n = 11), while in 8.9% (95% CI: 4.2, 16.2) (n = 9) of the protocols a systematic review was cited but did not inform trial design.ConclusionsA relatively high percentage of protocols of randomised trials involves prior citation of randomised trials, systematic reviews or both. However, improvements are required to ensure that it is explicit that clinical trials are justified and shaped by contemporary best evidence.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1713-6) contains supplementary material, which is available to authorized users.
Highlights
It is important that planned randomised trials are justified and placed in the context of the available evidence
It is accepted that relevant research, including systematic reviews where they exist and randomised trials, should be cited in the introduction section of reports of randomised controlled trials (RCTs) [3]
No commitment to data sharing was made in the majority of protocols (n = 93, 92.0%), 7% (n = 7) reported that data will be available upon request and only one (1%) protocol indicated the data repository
Summary
It is important that planned randomised trials are justified and placed in the context of the available evidence. The SPIRIT guidelines for reporting clinical trial protocols recommend that a recent and relevant systematic review should be included. It is accepted that relevant research, including systematic reviews where they exist and randomised trials, should be cited in the introduction section of reports of randomised controlled trials (RCTs) [3]. Within the SPIRIT guidelines, citation of prior research in the introduction section and justification of randomised trials on the basis of gaps in the underlying evidence base are advocated [7]. The SPIRIT checklist strongly recommends placing: “The trial in the context of available evidence, it is strongly recommended that an up-to-date systematic review of relevant studies be summarised and cited in the protocol.”
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