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A practical guide to simulation for an adaptive trial design with a single interim analysis.

Kaushala S Jayawardana1,2, Michael Dymock3,4, Robert K Mahar5,6,7

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This tutorial demonstrates simulating adaptive trial designs, crucial for flexible and efficient clinical studies. It provides accessible R and Stata code to help researchers balance statistical power and sample size.

Keywords:
Adaptive trialsSample sizeSimulationTrial design

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Pharmaceutical Research

Background:

  • Adaptive trial designs offer flexibility and efficiency over traditional fixed designs.
  • Planned modifications based on accumulating data are key features of adaptive trials.
  • Simulation is essential for adaptive trial design due to the inability of analytical formulae to account for data-driven adaptations.

Purpose of the Study:

  • To demonstrate simulating data from a simple adaptive trial with a single interim analysis.
  • To provide a foundational framework for making adaptive trial simulation more accessible.
  • To aid statisticians and clinicians in designing adaptive trials.

Main Methods:

  • Simulation of data from an adaptive trial with one interim analysis.
  • Summarizing simulation results to balance type I error and power.
  • Utilizing R and Stata programming languages with modular code for comprehensibility.

Main Results:

  • The simulation results inform study design by balancing type I error and power.
  • Expected sample size can be determined through simulation.
  • The provided code facilitates the generation of various adaptive designs.

Conclusions:

  • Simulation must be tailored to the specific design requirements of each adaptive trial.
  • This tutorial offers a framework to enhance the accessibility of adaptive trial simulation.
  • The goal is to empower both statisticians and clinicians in utilizing adaptive trial designs.