SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

2010 • 12,621 citations

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

2013 • 4,581 citations

CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials

2010 • 3,250 citations

Empirical Evidence for Selective Reporting of Outcomes in Randomized Trials

2004 • 1,728 citations

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

2008 • 1,460 citations

Guidance for Developers of Health Research Reporting Guidelines

2010 • 1,127 citations

Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa

2012 • 541 citations

ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice.

2002 • 511 citations

The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed

2010 • 496 citations

Ghost Authorship in Industry-Initiated Randomised Trials

2007 • 269 citations

Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)

2005 • 222 citations

Comparison of protocols and registry entries to published reports for randomised controlled trials

2011 • 214 citations

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists

2011 • 205 citations

Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study

2005 • 200 citations

Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

2008 • 195 citations

Clinical trial registration: transparency is the watchword

2006 • 164 citations

The Good Clinical Practice guideline: a bronze standard for clinical research

2005 • 151 citations

A National Cancer Clinical Trials System for the 21st Century

2010 • 128 citations

Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications

2012 • 103 citations

Adverse Event Reporting in Publications Compared With Sponsor Database for Cancer Clinical Trials

2006 • 101 citations

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

2012 • 86 citations

Measuring the Incidence, Causes, and Repercussions of Protocol Amendments

2011 • 68 citations

Developing a guideline for clinical trial protocol content: Delphi consensus survey

2012 • 67 citations

Guidelines for randomized clinical trial protocol content: a systematic review

2012 • 67 citations

Out of sight but not out of mind: how to search for unpublished clinical trial evidence

2012 • 61 citations

Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory

2009 • 51 citations

Subgroup Analysis and Covariate Adjustment in Randomized Clinical Trials of Traumatic Brain Injury: A Systematic Review

2005 • 48 citations

Reporting of Methodologic Information on Trial Registries for Quality Assessment: A Study of Trial Records Retrieved from the WHO Search Portal

2010 • 47 citations

Registering Clinical Trial Results

2010 • 32 citations

Protocols, probity, and publication

2009 • 28 citations

Ethical Considerations in the Interpretation and Communication of Clinical Trial Results

2007 • 19 citations