Reporting of noninferiority trials was incomplete in trial registries

Dekkers, Olaf M; Soonawala, Darius; Vandenbroucke, Jan P; Egger, Matthias (2011). Reporting of noninferiority trials was incomplete in trial registries. Journal of clinical epidemiology, 64(9), pp. 1034-1038. New York, N.Y.: Elsevier 10.1016/j.jclinepi.2010.12.008

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Objective To examine the registration of noninferiority trials, with a focus on the reporting of study design and noninferiority margins. Study Design and Setting Cross-sectional study of registry records of noninferiority trials published from 2005 to 2009 and records of noninferiority trials in the International Standard Randomized Controlled Trial Number (ISRCTN) or ClinicalTrials.gov trial registries. The main outcome was the proportion of records that reported the noninferiority design and margin. Results We analyzed 87 registry records of published noninferiority trials and 149 registry records describing noninferiority trials. Thirty-five (40%) of 87 records from published trials described the trial as a noninferiority trial; only two (2%) reported the noninferiority margin. Reporting of the noninferiority design was more frequent in the ISRCTN registry (13 of 18 records, 72%) compared with ClinicalTrials.gov (22 of 69 records, 32%; P = 0.002). Among the 149 records identified in the registries, 13 (9%) reported the noninferiority margin. Only one of the industry-sponsored trial compared with 11 of the publicly funded trials reported the margin (P = 0.001). Conclusion Most registry records of noninferiority trials do not mention the noninferiority design and do not include the noninferiority margin. The registration of noninferiority trials is unsatisfactory and must be improved.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine

UniBE Contributor:

Egger, Matthias

ISSN:

0895-4356

Publisher:

Elsevier

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 14:22

Last Modified:

10 Sep 2017 17:37

Publisher DOI:

10.1016/j.jclinepi.2010.12.008

PubMed ID:

21444195

Web of Science ID:

000293813000012

BORIS DOI:

10.7892/boris.7314

URI:

https://boris.unibe.ch/id/eprint/7314 (FactScience: 212513)

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