Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial.

2.50
Hdl Handle:
http://hdl.handle.net/10541/85397
Title:
Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial.
Authors:
Sydes, Matthew R; Parmar, Mahesh K B; James, Nicholas D; Clarke, Noel W ( 0000-0001-7776-8059 ) ; Dearnaley, David P; Mason, Malcolm D; Morgan, Rachel C; Sanders, Karen; Royston, Patrick
Abstract:
BACKGROUND: The multi-arm multi-stage (MAMS) trial is a new paradigm for conducting randomised controlled trials that allows the simultaneous assessment of a number of research treatments against a single control arm. MAMS trials provide earlier answers and are potentially more cost-effective than a series of traditionally designed trials. Prostate cancer is the most common tumour in men and there is a need to improve outcomes for men with hormone-sensitive, advanced disease as quickly as possible. The MAMS design will potentially facilitate evaluation and testing of new therapies in this and other diseases. METHODS: STAMPEDE is an open-label, 5-stage, 6-arm randomised controlled trial using MAMS methodology for men with prostate cancer. It is the first trial of this design to use multiple arms and stages synchronously. RESULTS: The practical and statistical issues faced by STAMPEDE in implementing MAMS methodology are discussed and contrasted with those for traditional trials. These issues include the choice of intermediate and final outcome measures, sample size calculations and the impact of varying the assumptions, the process for moving between trial stages, stopping accrual to each trial arm and overall, and issues around perceived trial complexity. CONCLUSION: It is possible to use the MAMS design to initiate and undertake large scale cancer trials. The results from STAMPEDE will not be known for some years but the lessons learned from running a MAMS trial are shared in the hope that other researchers will use this exciting and efficient method to perform further randomised controlled trials. TRIAL REGISTRATION: ISRCTN78818544, NCT00268476.
Affiliation:
MRC Clinical Trials Unit, London, UK. matthew.sydes@ctu.mrc.ac.uk
Citation:
Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. 2009, 10:39 Trials
Journal:
Trials
Issue Date:
2009
URI:
http://hdl.handle.net/10541/85397
DOI:
10.1186/1745-6215-10-39
PubMed ID:
19519885
Type:
Article
Language:
en
ISSN:
1745-6215
Appears in Collections:
All Christie Publications ; Urological Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorSydes, Matthew Ren
dc.contributor.authorParmar, Mahesh K Ben
dc.contributor.authorJames, Nicholas Den
dc.contributor.authorClarke, Noel Wen
dc.contributor.authorDearnaley, David Pen
dc.contributor.authorMason, Malcolm Den
dc.contributor.authorMorgan, Rachel Cen
dc.contributor.authorSanders, Karenen
dc.contributor.authorRoyston, Patricken
dc.date.accessioned2009-11-05T10:38:39Z-
dc.date.available2009-11-05T10:38:39Z-
dc.date.issued2009-
dc.identifier.citationIssues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. 2009, 10:39 Trialsen
dc.identifier.issn1745-6215-
dc.identifier.pmid19519885-
dc.identifier.doi10.1186/1745-6215-10-39-
dc.identifier.urihttp://hdl.handle.net/10541/85397-
dc.description.abstractBACKGROUND: The multi-arm multi-stage (MAMS) trial is a new paradigm for conducting randomised controlled trials that allows the simultaneous assessment of a number of research treatments against a single control arm. MAMS trials provide earlier answers and are potentially more cost-effective than a series of traditionally designed trials. Prostate cancer is the most common tumour in men and there is a need to improve outcomes for men with hormone-sensitive, advanced disease as quickly as possible. The MAMS design will potentially facilitate evaluation and testing of new therapies in this and other diseases. METHODS: STAMPEDE is an open-label, 5-stage, 6-arm randomised controlled trial using MAMS methodology for men with prostate cancer. It is the first trial of this design to use multiple arms and stages synchronously. RESULTS: The practical and statistical issues faced by STAMPEDE in implementing MAMS methodology are discussed and contrasted with those for traditional trials. These issues include the choice of intermediate and final outcome measures, sample size calculations and the impact of varying the assumptions, the process for moving between trial stages, stopping accrual to each trial arm and overall, and issues around perceived trial complexity. CONCLUSION: It is possible to use the MAMS design to initiate and undertake large scale cancer trials. The results from STAMPEDE will not be known for some years but the lessons learned from running a MAMS trial are shared in the hope that other researchers will use this exciting and efficient method to perform further randomised controlled trials. TRIAL REGISTRATION: ISRCTN78818544, NCT00268476.en
dc.language.isoenen
dc.subjectProstatic Canceren
dc.subject.meshAndrogen Antagonists-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshData Interpretation, Statistical-
dc.subject.meshDiphosphonates-
dc.subject.meshDrug Therapy, Combination-
dc.subject.meshHumans-
dc.subject.meshImidazoles-
dc.subject.meshMale-
dc.subject.meshProstatic Neoplasms-
dc.subject.meshRandomized Controlled Trials as Topic-
dc.subject.meshSoftware-
dc.subject.meshTaxoids-
dc.titleIssues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial.en
dc.typeArticleen
dc.contributor.departmentMRC Clinical Trials Unit, London, UK. matthew.sydes@ctu.mrc.ac.uken
dc.identifier.journalTrialsen

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