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Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

Sydes, MR; Parmar, MK; Mason, MD; Clarke, NW; Amos, C; Anderson, J; de Bono, J; ... James, ND; + view all (2012) Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials , 13 , Article 168. 10.1186/1745-6215-13-168. Green open access

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Abstract

Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial.

Type: Article
Title: Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/1745-6215-13-168
Publisher version: http://dx.doi.org/10.1186/1745-6215-13-168
Language: English
Additional information: © 2012 Sydes et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. PMCID: PMC3466132
Keywords: Antineoplastic Agents, Hormonal, Disease-Free Survival, Great Britain, Humans, Male, Patient Selection, Prostatic Neoplasms, Research Design, Survival Analysis, Switzerland, Time Factors, Treatment Outcome
UCL classification: UCL
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 Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/1375820
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