ArticleTrials2014
An investigation of the impact of futility analysis in publicly funded trials.
Article in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Sulfonylurea drugs for people with severe hemispheric ischemic stroke.The Cochrane database of systematic reviews · 2025Pooled it
- Vaccines for the common cold.The Cochrane database of systematic reviews · 2022Pooled it
- A systematic survey of randomised trials that stopped early for reasons of futility.BMC medical research methodology · 2020Pooled it
- Adaptive trials in low back pain and osteoarthritis: How common are they and when should they be used? A systematic review from ClinicalTrials.gov.Osteoarthritis and cartilage open · 2026Review
- Adaptive designs in randomized clinical trials: reanalysis of the HOVON87/NMSG18 multiple myeloma trial.EClinicalMedicine · 2025Article
- Practical and analytical considerations when performing interim analyses in diagnostic test accuracy studies.Diagnostic and prognostic research · 2024Article
- The performance of a Bayesian value-based sequential clinical trial design in the presence of an equivocal cost-effectiveness signal: evidence from the HERO trial.BMC medical research methodology · 2024Article
- A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints.Trials · 2023Article
- Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.BMC medical research methodology · 2022Article
- Randomized Controlled Trials 1: Design.Methods in molecular biology (Clifton, N.J.) · 2021Article
- Caesarean delivery rates and analgesia effectiveness following injections of sterile water for back pain in labour: A multicentre, randomised placebo controlled trial.EClinicalMedicine · 2020Article
- Can testing clinical significance reduce false positive rates in randomized controlled trials? A snap review.BMC research notes · 2017Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPublicly funded trials regularly fail to recruit their target sample size or find a significant positive result. Adaptive clinical trials which may partly mediate against the problems are not often applied. In this paper we investigate the potential of a form of adaption in a clinical trial - a futility analysis - to see if it has potential to improve publicly funded trials.
methodsOutcome data from trials funded by two UK bodies, the Health Technology Assessment (HTA) programme and the UK Medical Research Council (MRC), were collected. These data were then used to simulate each trial with a single futility analysis using conditional power, undertaken after 50% to 90% of the patients had been recruited. Thirty-three trials recruiting between 2002 and 2008 met the inclusion criteria. Stopping boundaries of conditional powers of 20%, 30% and 40% were considered and outcomes included the number of trials successfully stopped and number of patients saved.
resultsInclusion of a futility analysis after 75% of the patients had been recruited would have potentially resulted in 10 trials, which went on to have negative results, correctly stopping for futility using a stopping boundary of 30%. A total of 807 patients across all the trials would potentially have been saved using these futility parameters. The proportion of studies successfully recruiting would also have increased from 45% to 64%.
conclusionsA futility assessment has the potential to increase efficiency, save patients and decrease costs in publicly funded trials. While there are logistical issues in undertaking futility assessments we recommend that investigators should aim to include a futility analysis in their trial design wherever possible.
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