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dc.contributor.authorSnowdon, C
dc.contributor.authorKernaghan, S
dc.contributor.authorMoretti, L
dc.contributor.authorTurner, NC
dc.contributor.authorRing, A
dc.contributor.authorWilkinson, K
dc.contributor.authorMartin, S
dc.contributor.authorFoster, S
dc.contributor.authorKilburn, LS
dc.contributor.authorBliss, JM
dc.date.accessioned2022-06-08T09:33:38Z
dc.date.available2022-06-08T09:33:38Z
dc.date.issued2022-05-07
dc.identifier.citationTrials, 2022, 23 (1), pp. 372 - ?
dc.identifier.issn1745-6215
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5172
dc.identifier.eissn1745-6215
dc.identifier.eissn1745-6215
dc.identifier.doi10.1186/s13063-022-06312-x
dc.identifier.doi10.1186/s13063-022-06312-x
dc.description.abstractBACKGROUND: Platform trial designs are used increasingly in cancer clinical research and are considered an efficient model for evaluating multiple compounds within a single disease or disease subtype. However, these trial designs can be challenging to operationalise. The use of platform trials in oncology clinical research has increased considerably in recent years as advances in molecular biology enable molecularly defined stratification of patient populations and targeted therapy evaluation. Whereas multiple separate trials may be deemed infeasible, platform designs allow efficient, parallel evaluation of multiple targeted therapies in relatively small biologically defined patient sub-populations with the promise of increased molecular screening efficiency and reduced time for drug evaluation. Whilst the theoretical efficiencies are widely reported, the operational challenges associated with these designs (complexity, cost, regulatory, resource) are not always well understood. MAIN: In this commentary, we describe our practical experience of the implementation and delivery of the UK plasmaMATCH trial, a platform trial in advanced breast cancer, comprising an integrated screening component and multiple parallel downstream mutation-directed therapeutic cohorts. plasmaMATCH reported its primary results within 3 years of opening to recruitment. We reflect on the operational challenges encountered and share lessons learnt to inform the successful conduct of future trials. Key to the success of the plasmaMATCH trial was well co-ordinated stakeholder engagement by an experienced clinical trials unit with expert methodology and trial management expertise, a federated model of clinical leadership, a well-written protocol integrating screening and treatment components and including justification for the chosen structure and intentions for future adaptions, and an integrated funding model with streamlined contractual arrangements across multiple partners. Findings based on our practical experience include the importance of early engagement with the regulators and consideration of a flexible resource infrastructure to allow adequate resource allocation to support concurrent trial activities as adaptions are implemented in parallel to the continued management of patient safety and data quality of the ongoing trial cohorts. CONCLUSION: Platform trial designs allow the efficient reporting of multiple treatment cohorts. Operational challenges can be overcome through multidisciplinary engagement, streamlined contracting processes, rationalised protocol and database design and appropriate resourcing.
dc.formatElectronic
dc.format.extent372 - ?
dc.languageeng
dc.language.isoeng
dc.publisherBMC
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectCohort Studies
dc.subjectResearch Design
dc.subjectFemale
dc.subjectClinical Trials, Phase II as Topic
dc.subjectData Management
dc.titleOperational complexity versus design efficiency: challenges of implementing a phase IIa multiple parallel cohort targeted treatment platform trial in advanced breast cancer.
dc.typeJournal Article
dcterms.dateAccepted2022-03-23
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1186/s13063-022-06312-x
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2022-05-07
dc.relation.isPartOfTrials
pubs.issue1
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.publication-statusPublished
pubs.volume23
pubs.embargo.termsNot known
icr.researchteamMolecular Oncology
icr.researchteamClinical Trials & Statistics Unit
dc.contributor.icrauthorSnowdon, Claire
dc.contributor.icrauthorTurner, Nicholas
dc.contributor.icrauthorKilburn, Lucy
dc.contributor.icrauthorBliss, Judith


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