Evidence map›Paper›PMID 35273052›Full record

Trial reportBMJ open2022

Uptake of the multi-arm multi-stage (MAMS) adaptive platform approach: a trial-registry review of late-phase randomised clinical trials.

Nurulamin M Noor, Sharon B Love, Talia Isaacs, Richard Kaplan, Mahesh K B Parmar, Matthew R Sydes

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 3 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  19. INCEPT: The Intensive Care Platform Trial-Design and protocol.Acta anaesthesiologica Scandinavica · 2025
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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

6 authors.

Nurulamin M NoorMRC Clinical Trials Unit at UCL, London, UK noorn@doctors.org.uk.ORCID 0000-0003-3426-6408
Sharon B LoveMRC Clinical Trials Unit at UCL, London, UK.
Talia IsaacsInstitute of Education, University College London, London, UK.
Richard KaplanMRC Clinical Trials Unit at UCL, London, UK.
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, London, UK.ORCID 0000-0003-0166-1700
Matthew R SydesMRC Clinical Trials Unit at UCL, London, UK.ORCID 0000-0002-9323-1371

Funding

Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_00004/09Medical Research Council MC_UU_12023/24Medical Research Council MC_UU_12023/29
6 · The paper itself

Abstract

backgroundFor medical conditions with numerous interventions worthy of investigation, there are many advantages of a multi-arm multi-stage (MAMS) platform trial approach. However, there is currently limited knowledge on uptake of the MAMS design, especially in the late-phase setting. We sought to examine uptake and characteristics of late-phase MAMS platform trials, to enable better planning for teams considering future use of this approach.

designWe examined uptake of registered, late-phase MAMS platforms in the EU clinical trials register, Australian New Zealand Clinical Trials Registry, International Standard Randomised Controlled Trial Number registry, Pan African Clinical Trials Registry, WHO International Clinical Trial Registry Platform and databases: PubMed, Medline, Cochrane Library, Global Health Library and EMBASE. Searching was performed and review data frozen on 1 April 2021. MAMS platforms were defined as requiring two or more comparison arms, with two or more trial stages, with an interim analysis allowing for stopping of recruitment to arms and typically the ability to add new intervention arms.

results62 late-phase clinical trials using an MAMS approach were included. Overall, the number of late-phase trials using the MAMS design has been increasing since 2001 and been accelerated by COVID-19. The majority of current MAMS platforms were either targeting infectious diseases (52%) or cancers (29%) and all identified trials were for treatment interventions. 89% (55/62) of MAMS platforms were evaluating medications, with 45% (28/62) of the MAMS platforms having at least one or more repurposed medication as a comparison arm.

conclusionsHistorically, late-phase trials have adhered to long-established standard (two-arm) designs. However, the number of late-phase MAMS platform trials is increasing, across a range of different disease areas. This study highlights the potential scope of MAMS platform trials and may assist research teams considering use of this approach in the late-phase randomised clinical trial setting. PROSPERO REGISTRATION NUMBER: CRD42019153910.

Indexed as

COVID-19Adaptive Clinical Trials as TopicAustraliaData ManagementHumansRegistriesResearch Designclinical pharmacologyclinical trialsinfectious diseasesoncologypublic health

Identifiers

PMID35273052
PMCPMC8915371

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.