Prevalence, characteristics, and publication of discontinued randomized trials.

Détails

Ressource 1Télécharger: 5_24618966.pdf (737.12 [Ko])
Etat: Serval
Version: Final published version
ID Serval
serval:BIB_4BD40193B614
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Prevalence, characteristics, and publication of discontinued randomized trials.
Périodique
Jama
Auteur(s)
Kasenda B., von Elm E., You J., Blümle A., Tomonaga Y., Saccilotto R., Amstutz A., Bengough T., Meerpohl J.J., Stegert M., Tikkinen K.A., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla S.M., Mertz D., Akl E.A., Bassler D., Busse J.W., Ferreira-González I., Lamontagne F., Nordmann A., Gloy V., Raatz H., Moja L., Rosenthal R., Ebrahim S., Schandelmaier S., Xin S., Vandvik P.O., Johnston B.C., Walter M.A., Burnand B., Schwenkglenks M., Hemkens L.G., Bucher H.C., Guyatt G.H., Briel M.
ISSN
1538-3598 (Electronic)
ISSN-L
0098-7484
Statut éditorial
Publié
Date de publication
2014
Peer-reviewed
Oui
Volume
311
Numéro
10
Pages
1045-1051
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Résumé
IMPORTANCE: The discontinuation of randomized clinical trials (RCTs) raises ethical concerns and often wastes scarce research resources. The epidemiology of discontinued RCTs, however, remains unclear.
OBJECTIVES: 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.
DESIGN AND SETTING: 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.
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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).
CONCLUSIONS AND RELEVANCE: 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.
Mots-clé
Canada, Cohort Studies, Ethics Committees, Research, Germany, Humans, Odds Ratio, Patient Selection, Publication Bias, Randomized Controlled Trials as Topic/ethics, Randomized Controlled Trials as Topic/statistics & numerical data, Retrospective Studies, Switzerland
Pubmed
Web of science
Open Access
Oui
Création de la notice
11/04/2014 18:39
Dernière modification de la notice
08/05/2019 18:15
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