Integrity of randomized controlled trials: challenges and solutions

Wentao Li* (Corresponding Author), Madelon van Wely, Lyle Gurrin, Ben W. Mol

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

16 Citations (Scopus)


There has been increasing concern about compromised integrity in randomized controlled trials (RCTs) because it undermines the authority of this top-level evidence-generating method and puts patients at risk. Compromised RCTs also jeopardize the validity of systematic reviews and meta-analyses when they are included. The publication-driven research environment is responsible for the emergence of integrity issues in RCTs, which has been facilitated by insufficient efforts to prevent, identify, and disclose research misconduct. The ability to assess integrity in RCTs is important to deter research misconduct. Data integrity in RCTs can be assessed in three domains: general assessment, analysis with summary data, and individual participant data check. Statistical methods play an important role in finding evidence against data fabrication or falsification in RCTs. It is important to strictly implement the prospective registration policy and the Consolidated Standards of Reporting Trials (CONSORT) statement for RCT publication, but more effort needs to be devoted to developing and validating statistical methods that identify different patterns of data manipulation. Ideally the system of submission, review, and publication would be reformed in a way that allows the timely investigation and retraction of compromised RCTs. Authors of systematic reviews should be aware of the uncertainty posed by compromised RCTs to the quality of synthesized evidence, and they should participate in the campaign to fight compromised integrity.

Original languageEnglish
Pages (from-to)1113-1119
Number of pages7
JournalFertility and Sterility
Issue number6
Early online date6 May 2020
Publication statusPublished - Jun 2020

Bibliographical note

Copyright © 2020 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.


  • Fabrication
  • falsification
  • meta-analysis
  • randomized clinical trial
  • research integrity


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