Format

Send to

Choose Destination
J Am Coll Cardiol. 2015 Dec 15;66(23):2648-2662. doi: 10.1016/j.jacc.2015.10.023.

Statistical Controversies in Reporting of Clinical Trials: Part 2 of a 4-Part Series on Statistics for Clinical Trials.

Author information

1
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom. Electronic address: Stuart.Pocock@LSHTM.ac.uk.
2
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
3
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.

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.

KEYWORDS:

intention-to-treat analysis; logistic models; proportional hazards models; randomized controlled trials as topic; risk assessment; statistics

PMID:
26670066
DOI:
10.1016/j.jacc.2015.10.023
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center