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Discrepancies between registration and publication of randomised controlled trials: an observational study

Kate F Walker1, Graham Stevenson2, James G Thornton1

  • 1Academic Division of Obstetrics and Gynaecology, Maternity Department, University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham NG5 1PB, UK.

JRSM Open
|July 25, 2014
PubMed

Insights

Discrepancies between trial registration and publication are common for randomized controlled trials (RCTs). Ensuring complete registry information is crucial for meaningful trial registration and accurate reporting of outcomes and sample size.

Area of Science:

  • Clinical Trials
  • Medical Research Methodology
  • Publication Ethics

Background:

  • Randomized controlled trials (RCTs) are essential for evidence-based medicine.
  • Trial registration aims to improve transparency and reduce bias.
  • Inconsistencies between registered information and published results can undermine research integrity.

Purpose of the Study:

  • To assess the consistency between the registration and publication data of randomized controlled trials (RCTs).
  • To identify discrepancies in outcomes and sample size between trial registries and published articles.

Main Methods:

  • Observational study of RCTs published in BMJ and JAMA between May 2011 and May 2012.
  • Comparison of data from trial registries with data from published trial reports.
  • Analysis of timing of registration, primary/secondary outcomes, and sample size.

Main Results:

  • A high percentage of RCTs in BMJ (98%) and JAMA (100%) were registered prior to publication.
  • Discrepancies in primary outcomes were found in 47% of BMJ and 19% of JAMA publications.
  • Achieved sample size matched registration in 60% of BMJ and 58% of JAMA trials.

Conclusions:

  • Significant discrepancies persist between RCT registration and publication data.
  • Incomplete registry information and outcome/sample size variations compromise the value of mandatory trial registration.
  • Strengthens the call for mandatory completion of minimum data fields in trial registries, as advocated by the WHO.
Abstract

Keywords:
clinical trialconsensus development conferencerandomised controlled trial

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