An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.
Détails
ID Serval
serval:BIB_00F7DB12F80C
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.
Périodique
Journal of Clinical Epidemiology
Collaborateur⸱rice⸱s
DISCO study group
Contributeur⸱rice⸱s
Stegert M., Kasenda B., von Elm E., You JJ., Blümle A., Tomonaga Y., Saccilotto R., Amstutz A., Bengough T., Meerpohl JJ., Tikkinen KA., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla S., Mertz D., Akl EA., Bassler D., Busse JW., Ferreira-González I., Lamontagne F., Nordmann A., Gloy V., Olu KK., Raatz H., Moja L., Rosenthal R., Ebrahim S., Schandelmaier S., Sun X., Vandvik PO., Johnston BC., Walter MA., Burnand B., Schwenkglenks M., Hemkens LG., Bucher HC., Guyatt GH., Briel M.
ISSN
1878-5921 (Electronic)
ISSN-L
0895-4356
Statut éditorial
Publié
Date de publication
2016
Peer-reviewed
Oui
Volume
69
Numéro
69
Pages
152-160
Langue
anglais
Notes
Publication types: Journal Article ; Review
Publication Status: ppublish
Publication Status: ppublish
Résumé
OBJECTIVES: To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications.
STUDY DESIGN AND SETTING: We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada.
RESULTS: Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%).
CONCLUSION: Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol.
STUDY DESIGN AND SETTING: We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada.
RESULTS: Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%).
CONCLUSION: Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol.
Mots-clé
Clinical Protocols, Clinical Trials Data Monitoring Committees, Early Termination of Clinical Trials/standards, Periodicals as Topic, Randomized Controlled Trials as Topic/standards
Pubmed
Web of science
Création de la notice
05/10/2015 11:23
Dernière modification de la notice
20/08/2019 13:23
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