Journal article

Integrity of randomized controlled trials: challenges and solutions

Wentao Li, Madelon van Wely, Lyle Gurrin, Ben W Mol

Fertility and Sterility | ELSEVIER SCIENCE INC | Published : 2020


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..

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