Evidence map›Paper›PMID 36068599›Full record

ArticleTrials2022

Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units.

Sharon B Love, Fay Cafferty, Claire Snowdon, Karen Carty, Joshua Savage, Philip Pallmann, Lucy McParland, Louise Brown, Lindsey Masters, Francesca Schiavone and 26 more

Abstract read
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
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  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Design considerations for future renoprotection trials in the era of multiple therapies for chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
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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

36 authors.

Sharon B LoveMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK. s.love@ucl.ac.uk.ORCID http://orcid.org/0000-0002-6695-5390
Fay CaffertyThe Institute of Cancer Research, London, SW7 3RP, UK.
Claire SnowdonThe Institute of Cancer Research, London, SW7 3RP, UK.
Karen CartyCancer Research UK Clinical Trials Unit, Level 0 The Beatson West of Scotland Cancer Centre, 1053 Great Western Road, Glasgow, G12 0YN, UK.
Joshua SavageCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Philip PallmannCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK.
Lucy McParlandPHASTAR, Bollo Lane, London, W4 5LE, UK.
Louise BrownMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Lindsey MastersMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Francesca SchiavoneMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Dominic HagueMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Stephen TownsendMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Claire AmosMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Annabelle SouthMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Kate SturgeonMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Ruth LangleyMRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Timothy MaughanUniversity of Oxford, Oxford, OX3 7DQ, UK.
Nicholas JamesThe Institute of Cancer Research, London, SW7 3RP, UK.
Emma HallThe Institute of Cancer Research, London, SW7 3RP, UK.
Sarah KernaghanThe Institute of Cancer Research, London, SW7 3RP, UK.
Judith BlissThe Institute of Cancer Research, London, SW7 3RP, UK.
Nick TurnerThe Institute of Cancer Research, London, SW7 3RP, UK.
Andrew TuttThe Institute of Cancer Research, London, SW3 6JB, UK.
Christina YapThe Institute of Cancer Research, London, SW7 3RP, UK.
Charlotte FirthCancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Anthony KongComprehensive Cancer Centre, King's College London, Guy's Campus, New Hunt's House, Room 2.36b, London, SE1 1UL, UK.
Hisham MehannaInstitute for Head and Neck Studies and Education, University of Birmingham, Birmingham, B15 2TT, UK.
Colin WattsInstitute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Robert HillsDoll Building, CTSU, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.
Ian ThomasCentre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park Way, Cardiff, CF14 4YS, UK.
Mhairi CoplandPaul O'Gorman Research Centre, Gartnavel General Hospital, Glasgow, G12 0YN, UK.
Sue BellClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
David Sebag-MontefioreLevel 4 Bexley Wing St James Institute of Oncology, Leeds, LS9 7TF, UK.
Robert JonesBeatson West of Scotland Cancer Centre, Glasgow, UK.
Mahesh K B Parmar *MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.
Matthew R Sydes *MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK.

Funding

Cancer Research UK 15015Cancer Research UK 24896Cancer Research UK 25350Cancer Research UK 25351Cancer Research UK 25354Cancer Research UK C22436/A25354Medical Research Council MC_UU_00004/01Medical Research Council MC_UU_00004/02Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_12023/24
6 · The paper itself

Abstract

backgroundLate-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be more efficient than traditional two-arm clinical trial designs but are not extensively used. We have gathered the experience of running a number of successful platform protocols together to present some operational recommendations.

methodsRepresentatives of six UK clinical trials units with experience in running late-phase platform protocols attended a 1-day meeting structured to discuss various practical aspects of running these trials. We report and give guidance on operational aspects which are either harder to implement compared to a traditional late-phase trial or are specific to platform protocols.

resultsWe present a list of practical recommendations for trialists intending to design and conduct late-phase platform protocols. Our recommendations cover the entire life cycle of a platform trial: from protocol development, obtaining funding, and trial set-up, to a wide range of operational and regulatory aspects such as staffing, oversight, data handling, and data management, to the reporting of results, with a particular focus on communication with trial participants and stakeholders as well as public and patient involvement. DISCUSSION: Platform protocols enable many questions to be answered efficiently to the benefit of patients. Our practical lessons from running platform trials will support trial teams in learning how to run these trials more effectively and efficiently.

Indexed as

Data ManagementResearch DesignAdaptive Clinical Trials as TopicHumansUnited KingdomBasket trialsComplex innovative designsMethodologyMulti-arm multi-stage trialsPlatform protocolsStratified medicineTrial conductUmbrella trials

Identifiers

PMID36068599
PMCPMC9449272

What OpenQuestion 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 OpenQuestion graph.