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The Replication of Equivalence Studies.

Charlotte Micheloud1, Leonhard Held1

  • 1Epidemiology, Biostatistics and Prevention Institute (EBPI) and Center for Reproducible Science (CRS), University of Zurich, Zurich, Switzerland.

Biometrical Journal. Biometrische Zeitschrift
|October 30, 2024
PubMed
Summary
This summary is machine-generated.

This study introduces novel methods, the two-trials rule and sceptical two one-sided tests (TOST), for analyzing replication studies with equivalence designs. These approaches enhance power and allow replication success even with nonsignificant findings.

Keywords:
Type‐I error controldesign of replication studiesequivalencereplicabilityscepticaltwo‐trials rule

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Area of Science:

  • Biostatistics
  • Reproducibility in Science

Background:

  • Replication studies are crucial for scientific credibility.
  • Existing methodologies primarily focus on superiority designs, neglecting equivalence designs.
  • A methodological gap exists for analyzing replication studies with equivalence designs.

Purpose of the Study:

  • To propose and evaluate new analytical methods for replication studies employing equivalence designs.
  • To address the lack of methodology for analyzing equivalence-based replication studies.
  • To provide tools for sample size calculation in replication studies.

Main Methods:

  • Adaptation of the two-trials rule and sceptical two one-sided tests (TOST) procedure from superiority settings.
  • Comparison of operating characteristics, including Type-I error rate and project power.
  • Application of the proposed methods to data from the Reproducibility Project: Cancer Biology.

Main Results:

  • Both proposed methods maintain the overall Type-I error rate.
  • The sceptical TOST procedure demonstrates increased project power and allows replication success with nonsignificant results.
  • The methods are applicable for sample size determination in replication studies.

Conclusions:

  • The proposed two-trials rule and sceptical TOST procedure offer robust methodologies for equivalence-based replication studies.
  • Sceptical TOST provides advantages in power and flexibility compared to traditional approaches.
  • These methods contribute to a more comprehensive framework for assessing scientific findings through replication.