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.
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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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