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Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design

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dc.contributor.author Prutsky, Gabriela J.
dc.contributor.author Domecq, Juan Pablo
dc.contributor.author Erwin, Patricia J.
dc.contributor.author Briel, Matthias
dc.contributor.author Montori, Victor M.
dc.contributor.author Akl, Elie A.
dc.contributor.author Meerpohl, Jorge J.
dc.contributor.author Bassler, Dirk
dc.contributor.author Schandelmaier, Stefan
dc.contributor.author Walter, Stephen D.
dc.contributor.author Zhou, Qi
dc.contributor.author Coello, Pablo Alonso
dc.contributor.author Moja, Lorenzo
dc.contributor.author Walter, Martin
dc.contributor.author Thorlund, Kristian
dc.contributor.author Glasziou, Paul
dc.contributor.author Kunz, Regina
dc.contributor.author Ferreira-Gonzalez, Ignacio
dc.contributor.author Busse, Jason
dc.contributor.author Sun, Xin
dc.contributor.author Kristiansen, Annette
dc.contributor.author Kasenda, Benjamin
dc.contributor.author Qasim-Agha, Osama
dc.contributor.author Pagano, Genaro
dc.contributor.author Pardo-Hernandez, Hector
dc.contributor.author Urrutia, Gerard
dc.contributor.author Murad, Muhammad Hassan
dc.contributor.author Guyatt, Gordon
dc.date.accessioned 2022-01-04T20:33:21Z
dc.date.available 2022-01-04T20:33:21Z
dc.date.issued 2013
dc.identifier.uri https://hdl.handle.net/20.500.12866/10782
dc.description.abstract Background: Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or planned RCTs respond to the publication of a truncated RCT addressing a similar question. Methods/design: We will conduct systematic reviews to update the searches of 210 truncated RCTs to identify similar trials ongoing at the time of publication, or started subsequently, to the truncated trials ('subsequent RCTs’). Reviewers will determine in duplicate the similarity between the truncated and subsequent trials. We will analyze the epidemiology, distribution, and predictors of subsequent RCTs. We will also contact authors of subsequent trials to determine reasons for beginning, continuing, or prematurely discontinuing their own trials, and the extent to which they rely on the estimates from truncated trials. Discussion: To the extent that investigators begin or continue subsequent trials they implicitly disagree with the decision to stop the truncated RCT because of an ethical mandate to administer the experimental treatment. The results of this study will help guide future decisions about when to stop RCTs early for benefit. en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartofseries Trials
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Humans en_US
dc.subject randomized controlled trial (topic) en_US
dc.subject publication en_US
dc.subject Time Factors en_US
dc.subject article en_US
dc.subject conflict of interest en_US
dc.subject Randomized Controlled Trials as Topic en_US
dc.subject sensitivity analysis en_US
dc.subject Research Design en_US
dc.subject Protocol en_US
dc.subject Systematic review en_US
dc.subject Evidence-Based Medicine en_US
dc.subject clinical research en_US
dc.subject controlled vocabulary en_US
dc.subject data extraction en_US
dc.subject Early Termination of Clinical Trials en_US
dc.subject Information Dissemination en_US
dc.subject journal impact factor en_US
dc.subject Periodicals as Topic en_US
dc.subject Randomized controlled trials stopped early for benefit en_US
dc.subject RCT en_US
dc.title Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/1745-6215-14-335
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#1.06.02
dc.relation.issn 1745-6215


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