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An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules

Stegert, Mihaela and Kasenda, Benjamin and von Elm, Erik and You, John J. and Blümle, Anette and Tomonaga, Yuki and Saccilotto, Ramon and Amstutz, Alain and Bengough, Theresa and Briel, Matthias and Disco study group, . (2016) An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules. Journal of Clinical Epidemiology, 69. pp. 152-160.

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Official URL: http://edoc.unibas.ch/53531/

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Abstract

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.; We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada.; 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%).; 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.
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:Elsevier
ISSN:0895-4356
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:06 Oct 2017 08:27
Deposited On:06 Oct 2017 08:27

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