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Prevalence, characteristics, and publication of discontinued randomized trials

Kasenda, Benjamin and von Elm, Erik and You, John and Blümle, Anette and Tomonaga, Yuki and Saccilotto, Ramon and Amstutz, Alain and Bengough, Theresa and Meerpohl, Joerg J. and Stegert, Mihaela and Tikkinen, Kari A. O. and Neumann, Ignacio and Carrasco-Labra, Alonso and Faulhaber, Markus and Mulla, Sohail M. and Mertz, Dominik and Akl, Elie A. and Bassler, Dirk and Busse, Jason W. and Ferreira-González, Ignacio and Lamontagne, Francois and Nordmann, Alain and Gloy, Viktoria and Raatz, Heike and Moja, Lorenzo and Rosenthal, Rachel and Ebrahim, Shanil and Schandelmaier, Stefan and Xin, Sun and Vandvik, Per O. and Johnston, Bradley C. and Walter, Martin A. and Burnand, Bernard and Schwenkglenks, Matthias and Hemkens, Lars G. and Bucher, Heiner C. and Guyatt, Gordon H. and Briel, Matthias. (2014) Prevalence, characteristics, and publication of discontinued randomized trials. Journal of the American Medical Association, 311 (10). pp. 1045-1051.

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Official URL: http://edoc.unibas.ch/53524/

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Abstract

The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear.; To determine the prevalence, characteristics, and publication history of discontinued RCTs and to investigate factors associated with RCT discontinuation due to poor recruitment and with nonpublication.; Retrospective cohort of RCTs based on archived protocols approved by 6 research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics and planned recruitment from included protocols. Last follow-up of RCTs was April 27, 2013.; Completion status, reported reasons for discontinuation, and publication status of RCTs as determined by correspondence with the research ethics committees, literature searches, and investigator surveys.; After a median follow-up of 11.6 years (range, 8.8-12.6 years), 253 of 1017 included RCTs were discontinued (24.9% [95% CI, 22.3%-27.6%]). Only 96 of 253 discontinuations (37.9% [95% CI, 32.0%-44.3%]) were reported to ethics committees. The most frequent reason for discontinuation was poor recruitment (101/1017; 9.9% [95% CI, 8.2%-12.0%]). In multivariable analysis, industry sponsorship vs investigator sponsorship (8.4% vs 26.5%; odds ratio [OR], 0.25 [95% CI, 0.15-0.43]; P < .001) and a larger planned sample size in increments of 100 (-0.7%; OR, 0.96 [95% CI, 0.92-1.00]; P = .04) were associated with lower rates of discontinuation due to poor recruitment. Discontinued trials were more likely to remain unpublished than completed trials (55.1% vs 33.6%; OR, 3.19 [95% CI, 2.29-4.43]; P < .001).; In this sample of trials based on RCT protocols from 6 research ethics committees, discontinuation was common, with poor recruitment being the most frequently reported reason. Greater efforts are needed to ensure the reporting of trial discontinuation to research ethics committees and the publication of results of discontinued trials.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Kasenda, Benjamin
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Medical Association
ISSN:0098-7484
e-ISSN:1538-3598
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:06 Oct 2017 08:45
Deposited On:06 Oct 2017 08:45

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