Abstract
BackgroundWhen designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. We conducted the INVEST (INVestigating the use of Evidence Synthesis in the design and analysis of clinical Trials) survey to summarise the current use of evidence synthesis in trial design and analysis, to capture opinions of trialists and methodologists on such use, and to understand any barriers.MethodsOur sampling frame was all delegates attending the International Clinical Trials Methodology Conference in November 2015. Respondents were asked to indicate (1) their views on the use of evidence synthesis in trial design and analysis, (2) their own use during the past 10 years and (3) the three greatest barriers to use in practice.ResultsOf approximately 638 attendees of the conference, 106 (17%) completed the survey, half of whom were statisticians. Support was generally high for using a description of previous evidence, a systematic review or a meta-analysis in trial design. Generally, respondents did not seem to be using evidence syntheses as often as they felt they should. For example, only 50% (42/84 relevant respondents) had used a meta-analysis to inform whether a trial is needed compared with 74% (62/84) indicating that this is desirable. Only 6% (5/81 relevant respondents) had used a value of information analysis to inform sample size calculations versus 22% (18/81) indicating support for this. Surprisingly large numbers of participants indicated support for, and previous use of, evidence syntheses in trial analysis. For example, 79% (79/100) of respondents indicated that external information about the treatment effect should be used to inform aspects of the analysis. The greatest perceived barrier to using evidence synthesis methods in trial design or analysis was time constraints, followed by a belief that the new trial was the first in the area.ConclusionsEvidence syntheses can be resource-intensive, but their use in informing the design, conduct and analysis of clinical trials is widely considered desirable. We advocate additional research, training and investment in resources dedicated to ways in which evidence syntheses can be undertaken more efficiently, offering the potential for cost savings in the long term.
Highlights
When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste
The survey in full is available in Additional file 1. Following details about their job role, job setting and the length of time that they had spent working in clinical trials, respondents who indicated that they had been involved in trial design were further asked questions about whether, and how, they have used evidence synthesis in practice
The subsets of respondents who indicated that they had been involved in trial design were used to contrast views on whether evidence synthesis methods should be used versus current use in practice
Summary
When designing and analysing clinical trials, using previous relevant information, perhaps in the form of evidence syntheses, can reduce research waste. When designing and analysing a clinical trial, it is important to look at previous evidence and use relevant information to inform aspects of the new trial, thereby reducing waste in research [1]. The analyst could attempt to account for potential flaws in the methodology of the new trial, such as the allocated treatment being unblinded to the patient or personnel, which can cause bias in the treatment effect estimate [15] External evidence about such bias might come from ‘meta-epidemiological’ studies and could be used to adjust the treatment effect estimate from the new study [16], allowing the analyst to assess the sensitivity of the findings
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