title: Statistical Controversies in Reporting of Clinical Trials: Part 2 of a 4-Part Series on Statistics for Clinical Trials.
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.
authors.affiliation: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom. Electronic address: Stuart.Pocock@LSHTM.ac.uk.
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.affiliation: Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
authors.forename: John J V
authors.initials: JJV
authors.lastname: McMurray
authors.affiliation: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, United Kingdom.
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Collier
mesh_terms: D002309:Cardiology / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006801:Humans; D010347:Patient Care Planning / Q000458:organization & administration*; D018579:Patient Selection; D012107:Research Design
keywords: intention-to-treat analysis; logistic models; proportional hazards models; randomized controlled trials as topic; risk assessment; statistics