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Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum

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dc.contributor.author Filbey, L
dc.contributor.author Zhu, JW
dc.contributor.author D'Angelo, F
dc.contributor.author Thabane, L
dc.contributor.author Khan, MS
dc.contributor.author Lewis, E
dc.contributor.author Patel, MR
dc.contributor.author Powell-Wiley, T
dc.contributor.author Miranda, J. Jaime
dc.contributor.author Zuhlke, L
dc.contributor.author Butler, J
dc.contributor.author Zannad, F
dc.contributor.author Van Spall, HGC
dc.date.accessioned 2023-04-16T04:38:14Z
dc.date.available 2023-04-16T04:38:14Z
dc.date.issued 2023
dc.identifier.uri https://hdl.handle.net/20.500.12866/13386
dc.description.abstract Participants enrolled in cardiovascular disease (CVD) randomized controlled trials are not often representative of the population living with the disease. Older adults, children, women, Black, Indigenous and People of Color, and people living in low- and middle-income countries are typically under-enrolled in trials relative to disease distribution. Treatment effect estimates of CVD therapies have been largely derived from trial evidence generated in White men without complex comorbidities, limiting the generalizability of evidence. This review highlights barriers and facilitators of trial enrollment, temporal trends, and the rationale for representativeness. It proposes strategies to increase representativeness in CVD trials, including trial designs that minimize the research burden on participants, inclusive recruitment practices and eligibility criteria, diversification of clinical trial leadership, and research capacity-building in under-represented regions. Implementation of such strategies could generate better and more generalizable evidence to reduce knowledge gaps and position the cardiovascular trial enterprise as a vehicle to counter existing healthcare inequalities. en_US
dc.language.iso eng
dc.publisher Oxford University Press
dc.relation.ispartofseries European Heart Journal
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Clinical trials en_US
dc.subject Equity en_US
dc.subject diversity en_US
dc.subject inclusion en_US
dc.subject Health equity‌ en_US
dc.subject Research equity en_US
dc.subject Trial representativeness en_US
dc.subject Trial eligibility en_US
dc.title Improving representativeness in trials: a call to action from the Global Cardiovascular Clinical Trialists Forum en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1093/eurheartj/ehac810
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.04
dc.relation.issn 1522-9645


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