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Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies

Jitlal, M; Khan, I; Lee, SM; Hackshaw, A; (2012) Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies. British Journal of Cancer , 107 (6) 910 - 917. 10.1038/bjc.2012.344. Green open access

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Abstract

Background: Many clinical trials show no overall benefit. We examined futility analyses applied to trials with different effect sizes. Methods: Ten randomised cancer trials were retrospectively analysed; target sample size reached in all. The hazard ratio indicated no overall benefit (n=5), or moderate (n=4) or large (n=1) treatment effects. Futility analyses were applied after 25, 50 and 75% of events were observed, or patients were recruited. Outcomes were conditional power (CP), and time and cost savings. Results: Futility analyses could stop some trials with no benefit, but not all. After observing 50% of the target number of events, 3 out of 5 trials with no benefit could be stopped early (low CPless than or equal to15%). Trial duration for two studies could be reduced by 4–24 months, saving £44 000–231 000, but the third had already stopped recruiting, hence no savings were made. However, of concern was that 2 of the 4 trials with moderate treatment effects could be stopped early at some point, although they eventually showed worthwhile benefits. Conclusions: Careful application of futility can lead to future patients in a trial not being given an ineffective treatment, and should therefore be used more often. A secondary consideration is that it could shorten trial duration and reduce costs. However, studies with modest treatment effects could be inappropriately stopped early. Unless there is very good evidence for futility, it is often best to continue to the planned end.

Type: Article
Title: Stopping clinical trials early for futility: retrospective analysis of several randomised clinical studies
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1038/bjc.2012.344
Publisher version: http://dx.doi.org/10.1038/bjc.2012.344
Language: English
Additional information: This work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ PMCID: PMC3464764
Keywords: Clinical trials, Phase II as topic, Early termination of clinical trials, Humans, Medical futility, Neoplasms, Odds ratio, Patient selection, Randomized controlled trials as topic, Research design, Retrospective studies, Treatment outcome
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > CRUK Cancer Trials Centre
URI: https://discovery.ucl.ac.uk/id/eprint/1400051
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