The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials

BMC Medical Research Methodology

Carrol Gamble¹  Mike Clarke²  Paula R Williamson¹  Elizabeth Conroy¹  Ashley P Jones¹ 

[1]Department of Biostatistics, Faculty of Health & Life Sciences University of Liverpool, Brownlow Street, Liverpool, L69 3GS, UK

[2]All Ireland Hub for Trials Methodology Research, Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queens University Belfast, Royal Hospitals, Grosvenor Road, Belfast, BT12 6BJ, UK

关键词: Design;    Planning;    Randomised controlled trial;    Meta-analysis;    Systematic review;   

Others  :  1125965
DOI  :  10.1186/1471-2288-13-50

 received in 2012-11-12, accepted in 2013-03-13,  发布年份 2013

【 摘 要 】

Background

A systematic review, with or without a meta-analysis, should be undertaken to determine if the research question of interest has already been answered before a new trial begins. There has been limited research on how systematic reviews are used within the design of new trials, the aims of this study were to investigate how systematic reviews of earlier trials are used in the planning and design of new randomised trials.

Methods

Documentation from the application process for all randomised trials funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) between 2006 and 2008 were obtained. This included the: commissioning brief (if appropriate), outline application, minutes of the Board meeting in which the outline application was discussed, full application, detailed project description, referee comments, investigator response to referee comments, Board minutes on the full application and the trial protocol. Data were extracted on references to systematic reviews and how any such reviews had been used in the planning and design of the trial.

Results

50 randomised trials were funded by NIHR HTA during this period and documentation was available for 48 of these. The cohort was predominately individually randomised parallel trials aiming to detect superiority between two treatments for a single primary outcome. 37 trials (77.1%) referenced a systematic review within the application and 20 of these (i.e. 41.7% of the total) used information contained in the systematic review in the design or planning of the new trial. The main areas in which systematic reviews were used were in the selection or definition of an outcome to be measured in the trial (7 of 37, 18.9%), the sample size calculation (7, 18.9%), the duration of follow up (8, 21.6%) and the approach to describing adverse events (9, 24.3%). Boards did not comment on the presence/absence or use of systematic reviews in any application.

Conclusions

Systematic reviews were referenced in most funded applications but just over half of these used the review to inform the design. There is an expectation from funders that applicants will use a systematic review to justify the need for a new trial but no expectation regarding further use of a systematic review to aid planning and design of the trial. Guidelines for applicants and funders should be developed to promote the use of systematic reviews in the design and planning of randomised trials, to optimise delivery of new studies informed by the most up-to-date evidence base and to minimise waste in research.

【 授权许可】

   
2013 Jones et al.; licensee BioMed Central Ltd.

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