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Related Experiment Videos

Subverting randomization in controlled trials

K F Schulz1

  • 1Division of Sexually Transmitted Disease Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

JAMA
|November 8, 1995
PubMed
Summary
This summary is machine-generated.

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Adequate randomization is crucial in clinical trials. Inadequate allocation concealment can lead to biased results, as investigators may subvert randomization, impacting treatment effect reporting.

Area of Science:

  • Clinical Trials Methodology
  • Research Integrity
  • Biomedical Research

Background:

  • Empirical evidence highlights the critical role of adequate randomization in controlled trials.
  • Inadequate allocation concealment is linked to inflated treatment effects compared to trials with proper concealment.
  • Investigator bias can compromise the integrity of randomized controlled trials.

Purpose of the Study:

  • To explore the methods used by investigators to subvert randomization.
  • To provide empirical evidence on the frequency of randomization "deciphering" or subversion.
  • To propose methodological recommendations to prevent such practices.

Main Methods:

  • Analysis of anonymous accounts detailing the subversion of randomization processes.

Related Experiment Videos

  • Categorization of subversion techniques from simple to complex operations.
  • Review of documented instances of allocation concealment breaches.

    • Main Results:

    • Investigators employ diverse and sophisticated methods to subvert randomization, ranging from simple envelope manipulation to complex file searches.
    • These breaches of allocation concealment are more frequent than commonly acknowledged.
    • Subverted randomization directly contributes to biased estimation of treatment effects.

    Conclusions:

    • The integrity of randomized controlled trials is threatened by the ease with which randomization can be subverted.
    • Methodological safeguards are necessary to prevent the subversion of allocation concealment.
    • Ensuring proper randomization is essential for reliable clinical trial outcomes and research validity.