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Multiplicity issues for platform trials with a shared control arm.

Xiaofei Bai1, Qiqi Deng1, Dacheng Liu1

  • 1Department of Biostatistics and Data Sciences, Boehringer-Ingelheim Pharmaceutical Inc., Ridgefield, Connecticut, USA.

Journal of Biopharmaceutical Statistics
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PubMed
Summary
This summary is machine-generated.

Platform trials with a common control arm demonstrate robust performance, comparable or superior to independent trials. These adaptive designs effectively manage type I error rate, false discovery rate, and power.

Keywords:
Platform trialfalse discovery ratefamilywise error ratetype I error control

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Pharmaceutical Research

Background:

  • Platform trials offer an efficient adaptive design for evaluating multiple treatments.
  • Concerns exist regarding error rates and operating characteristics compared to traditional independent trials.
  • Frequentist statistical frameworks are commonly applied to clinical trial analysis.

Purpose of the Study:

  • To analyze and compare error types in platform trials versus standard independent trials.
  • To address common misconceptions about platform trial designs.
  • To evaluate the statistical performance of platform trials under a frequentist approach.

Main Methods:

  • Comparative analysis of error rates (Type I, False Discovery Rate).
  • Evaluation of statistical power across different trial designs.
  • Application of frequentist statistical methods for performance assessment.

Main Results:

  • Platform trials exhibit well-controlled Type I error rates.
  • False discovery rates in platform trials are generally favorable.
  • Statistical power is comparable or enhanced in platform trials versus independent trials.
  • Commonly held "myths" regarding platform trial errors are debunked.

Conclusions:

  • Platform trials with a common control arm are statistically sound and efficient.
  • These designs maintain desirable operating characteristics, often outperforming individual trials.
  • The frequentist evaluation supports the validity and utility of platform trial designs.