Statistical controversies in reporting of clinical trials: part 2 of a 4-part series on statistics for clinical trials

Pocock, S. J., McMurray, J. J.V. and Collier, T. J. (2015) Statistical controversies in reporting of clinical trials: part 2 of a 4-part series on statistics for clinical trials. Journal of the American College of Cardiology, 66(23), pp. 2648-62. (doi: 10.1016/j.jacc.2015.10.023) (PMID:26670066)

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Abstract

This paper tackles several statistical controversies that are commonly faced when reporting a major clinical trial. Topics covered include: multiplicity of data, interpreting secondary endpoints and composite endpoints, the value of covariate adjustment, the traumas of subgroup analysis, assessing individual benefits and risks, alternatives to analysis by intention to treat, interpreting surprise findings (good and bad), and the overall quality of clinical trial reports. All is put in the context of topical cardiology trial examples and is geared to help trialists steer a wise course in their statistical reporting, thereby giving readers a balanced account of trial findings.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Pocock, S. J., McMurray, J. J.V., and Collier, T. J.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Journal of the American College of Cardiology
Publisher:Elsevier
ISSN:0735-1097
ISSN (Online):1558-3597
Published Online:07 December 2015

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