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Performance Evaluation of Interim Analysis in Bioequivalence Studies.

Naoki Isogawa1, Andy Grieve2, Ryota Ishii3

  • 1UCB Japan Co., Ltd., Shinjuku-ku, Japan. Naoki.Isogawa@ucb.com.

Therapeutic Innovation & Regulatory Science
|May 24, 2024
PubMed
Summary

For bioequivalence studies in Japan, group sequential designs are preferred over adaptive designs. Both methods showed similar performance in simulations, but group sequential designs are less complex.

Keywords:
Adaptive designGroup sequential designJapan guideline for bioequivalence study

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Clinical Trial Design
  • Regulatory Science

Background:

  • Japanese bioequivalence guidelines mandate a single pivotal study.
  • Resource constraints often limit the maximum number of participants in clinical trials.
  • Interim analysis allows for early bioequivalence evaluation within resource limits.

Purpose of the Study:

  • To compare the performance of group sequential and adaptive designs for bioequivalence evaluation at interim analysis.
  • To determine the optimal trial design under resource constraints for Japanese bioequivalence studies.
  • To evaluate designs considering a pre-defined maximum participant number.

Main Methods:

  • A simulation study was conducted to compare group sequential and adaptive designs.
  • The comparison focused on trials with a pre-defined maximum number of participants.
  • A Pocock-type alpha spending function was utilized, as bioequivalence is expected at interim analysis.

Main Results:

  • Both group sequential and adaptive designs demonstrated similar performance when using a Pocock-type alpha spending function.
  • The simulation results indicated comparable efficacy between the two design types under the specified conditions.
  • No significant performance difference was observed between the methods in the conducted simulations.

Conclusions:

  • Group sequential designs are preferable for bioequivalence studies in Japan due to their lower statistical and operational complexity compared to adaptive designs.
  • Despite similar simulation performance, the practical implementation favors group sequential methods.
  • The findings support the adoption of group sequential designs for efficient bioequivalence evaluations within resource limitations in Japan.