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

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    Authors
    Sydes, Matthew R
    Parmar, Mahesh K B
    James, Nicholas D
    Clarke, Noel W
    Dearnaley, David P
    Mason, Malcolm D
    Morgan, Rachel C
    Sanders, Karen
    Royston, Patrick
    Affiliation
    MRC Clinical Trials Unit, London, UK. matthew.sydes@ctu.mrc.ac.uk
    Issue Date
    2009
    
    Metadata
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    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.
    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
    URI
    http://hdl.handle.net/10541/85397
    DOI
    10.1186/1745-6215-10-39
    PubMed ID
    19519885
    Type
    Article
    Language
    en
    ISSN
    1745-6215
    ae974a485f413a2113503eed53cd6c53
    10.1186/1745-6215-10-39
    Scopus Count
    Collections
    All Christie Publications
    Urological Oncology

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