Evidence map›Paper›PMID 19519885›Full record

Trial reportTrials2009

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

Matthew R Sydes, Mahesh K B Parmar, Nicholas D James, Noel W Clarke, David P Dearnaley, Malcolm D Mason, Rachel C Morgan, Karen Sanders, Patrick Royston

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00268476 (STAMPEDE), which is not on this map. Cited by 76 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
76citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00268476 phase2 / phase3active not recruitingnot on this map

STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial

TypeinterventionalSponsorMedical Research CouncilRan2005 to 2030Enrolled11,992ConditionsProstate CancerArmsCelecoxib, Docetaxel, Prednisolone, ADT, Zoledronic Acid
3 · Its place in the literature

Who cites it

76 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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16 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Matthew R SydesMRC Clinical Trials Unit, London, UK. matthew.sydes@ctu.mrc.ac.uk
Mahesh K B Parmar
Nicholas D James
Noel W Clarke
David P Dearnaley
Malcolm D Mason
Rachel C Morgan
Karen Sanders
Patrick Royston

Funding

Cancer Research UK 10588Cancer Research UK 3804Medical Research Council G0500966Medical Research Council G0501019Medical Research Council MC_U122861330
6 · The paper itself

Abstract

backgroundThe 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.

methodsSTAMPEDE 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.

resultsThe 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.

conclusionIt 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 registrationISRCTN78818544, NCT00268476.

Indexed as

Androgen AntagonistsAntineoplastic AgentsData Interpretation, StatisticalDiphosphonatesDocetaxelDrug Therapy, CombinationHumansImidazolesMaleProstatic NeoplasmsRandomized Controlled Trials as TopicSoftwareTaxoidsZoledronic AcidAndrogen AntagonistsAntineoplastic AgentsDiphosphonatesDocetaxelImidazolesTaxoidsZoledronic Acid

Identifiers

PMID19519885
PMCPMC2704188

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.