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Issues in planning and interpreting active control equivalence studies.

R Makuch1, M Johnson

  • 1Yale University School of Medicine, Division of Biostatistics, New Haven, CT 06510.

Journal of Clinical Epidemiology
|January 1, 1989
PubMed
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Active control equivalence studies (ACES) are increasingly common for new drug development. These trials rely on a historical control assumption, ensuring the active control drug is superior to placebo for valid efficacy conclusions.

Area of Science:

  • Clinical Trials
  • Pharmacology
  • Medical Research Methodology

Background:

  • Active control equivalence studies (ACES) are increasingly utilized for new therapeutic development.
  • Ethical considerations often preclude placebo-controlled trials, necessitating alternative designs.
  • ACES present unique methodological challenges, particularly regarding internal study validation.

Purpose of the Study:

  • To highlight the critical reliance on a "historical control assumption" in ACES.
  • To outline strategies for ensuring the validity of this assumption in study design.
  • To provide guidance on justifying the use of ACES.

Main Methods:

  • Emphasis on the "historical control assumption" inherent in ACES.
  • Discussion of methods to ensure the applicability of historical efficacy data.

Related Experiment Videos

  • Illustration using a planned stroke prevention study with aspirin as the active control.

    • Main Results:

    • ACES require the assumption that the active control would outperform a placebo.
    • Justification of ACES depends on the relevance of historical control efficacy data.
    • The study provides a framework for validating this assumption.

    Conclusions:

    • The "historical control assumption" is fundamental for interpreting ACES results.
    • Careful design and justification are crucial for the successful implementation of ACES.
    • This approach is vital for evaluating new treatments when placebo controls are unethical.