Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials

In a systematic review of cohort studies, Kerry Dwan and colleagues examine the evidence for selective reporting and discrepancies in analyses between journal publications and other documents for clinical trials. Please see later in the article for the Editors' Summary

[1]  D G Altman,et al.  Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists , 2011, BMJ : British Medical Journal.

[2]  J. Habbema,et al.  Subgroup Analysis and Covariate Adjustment in Randomized Clinical Trials of Traumatic Brain Injury: A Systematic Review , 2005, Neurosurgery.

[3]  M. Page,et al.  Many scenarios exist for selective inclusion and reporting of results in randomized trials and systematic reviews. , 2013, Journal of clinical epidemiology.

[4]  B. Djulbegovic,et al.  Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group , 2004, BMJ : British Medical Journal.

[5]  C D Naylor,et al.  Subgroups, treatment effects, and baseline risks: some lessons from major cardiovascular trials. , 2000, American heart journal.

[6]  P. Williamson,et al.  Bias in meta‐analysis due to outcome variable selection within studies , 2000 .

[7]  S. Assmann,et al.  Subgroup analysis and other (mis)uses of baseline data in clinical trials , 2000, The Lancet.

[8]  J. Habbema,et al.  Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading? , 2006, American heart journal.

[9]  Nazmus Saquib,et al.  Practices and impact of primary outcome adjustment in randomized controlled trials: meta-epidemiologic study , 2013, BMJ.

[10]  David Moher,et al.  SPIRIT 2013 Statement: defining standard protocol items for clinical trials. , 2015, Revista panamericana de salud publica = Pan American journal of public health.

[11]  Stephen W Lagakos,et al.  Statistics in medicine--reporting of subgroup analyses in clinical trials. , 2007, The New England journal of medicine.

[12]  Lisa Bero,et al.  Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation , 2008, PLoS medicine.

[13]  S. Evans,et al.  Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet , 2008, The Lancet.

[14]  J. Abraham The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use , 2009 .

[15]  R. Rosenthal,et al.  Selective publication of antidepressant trials and its influence on apparent efficacy. , 2008, The New England journal of medicine.

[16]  B. Beermann,et al.  Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications , 2003, BMJ : British Medical Journal.

[17]  Ich Harmonised,et al.  INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE , 2006 .

[18]  S. Hahn,et al.  Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. , 2002, Journal of evaluation in clinical practice.

[19]  Douglas G Altman,et al.  Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols , 2008, BMJ : British Medical Journal.

[20]  F. Song,et al.  Dissemination and publication of research findings: an updated review of related biases. , 2010, Health technology assessment.

[21]  Lisa M. Schwartz,et al.  Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review , 2010, BMJ : British Medical Journal.

[22]  G. Guyatt,et al.  The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review , 2011, BMJ : British Medical Journal.

[23]  Holger J Schünemann,et al.  Misuse of Baseline Comparison Tests and Subgroup Analyses in Surgical Trials , 2006, Clinical orthopaedics and related research.

[24]  G. Guyatt,et al.  Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study) , 2012, BMC Medical Research Methodology.

[25]  A. Hoes,et al.  American Journal of Epidemiology Practice of Epidemiology a Comparison of Subgroup Analyses in Grant Applications and Publications , 2022 .

[26]  D. Moher,et al.  CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials , 2010, Journal of pharmacology & pharmacotherapeutics.

[27]  E. Susser,et al.  Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals. , 2001, Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas.

[28]  D. Rennie,et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials. , 2013, Annals of internal medicine.

[29]  D. Altman,et al.  Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review , 2010, Trials.

[30]  Douglas G Altman,et al.  Comparison of protocols and registry entries to published reports for randomised controlled trials. , 2011, The Cochrane database of systematic reviews.

[31]  K. Dwan,et al.  Comparison of Randomized Controlled Trial Registry Entries and Content of Reports in Surgery Journals , 2013, Annals of surgery.

[32]  Douglas G Altman,et al.  Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. , 2010, JAMA.

[33]  Isabelle Boutron,et al.  Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals , 2013, PLoS medicine.

[34]  S. Vedula,et al.  Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin , 2013, PLoS medicine.