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An algorithm for the design of group sequential triangular tests for single-arm clinical trials with a binary

Thomas P McWilliams1

  • 1Decision Sciences Department, Drexel University, Philadelphia, PA 19104, USA. tmcwilliams@drexel.edu

Statistics in Medicine
|September 23, 2010
PubMed
Summary

A new algorithm for triangular testing (TT) designs ensures error specifications are met, unlike existing methods. This approach optimizes sample size and maintains desired Type I error and power for clinical trials.

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Inference

Background:

  • Group sequential tests offer efficiency over single-stage tests in clinical trials.
  • Existing triangular test designs (WTTs) may fail to meet Type I error or power specifications.
  • WTTs can be over-powered, increasing the number of subjects unnecessarily.

Purpose of the Study:

  • To introduce a novel search algorithm for generating algorithm-determined triangular test (ATT) designs.
  • To demonstrate that ATT designs consistently meet specified Type I error and power constraints.
  • To compare the performance of ATT designs against Whitehead's triangular test (WTT) designs.

Main Methods:

  • A search algorithm was developed to create triangular test designs.
  • Nearly 1000 combinations of group size (n), null hypothesis proportion (p0), alternative hypothesis proportion (p1), Type I error rate (α), and Type II error rate (β) were tested.
  • ATT and WTT designs were evaluated for their adherence to error specifications and average sample number (ASN).

Main Results:

  • ATT designs met specified Type I error and power constraints in all tested cases.
  • WTT designs met constraints in only 10 out of nearly 1000 tested combinations.
  • ATT designs showed favorable ASN performance, often with a modest reduction compared to WTTs when both met constraints.

Conclusions:

  • The developed search algorithm provides a reliable method for generating triangular test designs that meet statistical error specifications.
  • ATT designs offer a superior alternative to WTTs, ensuring accuracy and potentially reducing the number of subjects needed in clinical trials.
  • The algorithm-generated designs are efficient and maintain desired statistical properties, leading to improved clinical trial design.