The use of systematic reviews in the planning, design and conduct of randomised trials: a retrospective cohort of NIHR HTA funded trials
Open accessAbstract
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.
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Evidence from systematic review can help researchers optimise usefulness of new trial by informing design aspects such as outcome definition and sample size.
“This evidence can also help researchers to optimise the usefulness of the new trial by informing design aspects such as outcome definition and sample size.143 144 145”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [143]
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- Authors
- Jones, A. P., Conroy, E., Williamson, P. R., Clarke, M., & Gamble, C.
- Affiliations
- University of Liverpool (GB)
- Queen's University Belfast (GB)
- Corresponding author
- Jones, Ashley P
- Venue
- BMC Medical Research Methodology
- Published
- 2013-03-25
- Volume
- 13
- Issue
- 1
- Pages
- 50-50
- ISSN
- 1471-2288 (ISSN-L)
- PMC
- PMC3621166
- OpenAlex
- W2000066094
- Cited by
- 72
- References
- 12
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 4 · 2022: 4 · 2021: 14 · 2020: 4 · 2019: 4 · 2018: 3 · 2017: 3 · 2016: 4 · 2015: 14 · 2014: 9 · 2013: 2
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medical Research Methodology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Medical Research Council (G0800792)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- systematic reviews, randomized trial design, trial planning, sample size determination, outcome selection, follow-up duration, adverse events, research waste, evidence base, meta-analysis
- MeSH terms
- United Kingdom, Humans, Research Design, Review Literature as Topic, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Databases, Bibliographic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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