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Single-arm phase II trial design under parametric cure models.

Jianrong Wu1

  • 1Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, 38105, TN, USA.

Pharmaceutical Statistics
|April 8, 2015
PubMed
Summary
This summary is machine-generated.

This study introduces a new method for designing single-arm phase II survival trials, addressing limitations of current models when some patients are cured. The proposed parametric cure model offers a more accurate approach for sample size determination in clinical trial design.

Keywords:
clinical trial designcure modelsample sizesingle-arm phase II trialtime-to-event

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Survival Analysis

Background:

  • Current single-arm phase II survival trial designs often use the exponential model, which is unsuitable for scenarios where a fraction of patients achieve a cure.
  • Existing literature lacks guidance for designing these trials under parametric cure models.

Purpose of the Study:

  • To propose a novel test statistic and derive a sample size formula for single-arm phase II survival trials.
  • To enable robust trial design under a class of parametric cure models, accommodating patient cure.

Main Methods:

  • Development of a new test statistic tailored for parametric cure models.
  • Derivation of a sample size formula based on the proposed test statistic.
  • Extensive simulation studies to evaluate performance.

Main Results:

  • The proposed test statistic and sample size formula demonstrate strong performance across various simulated scenarios.
  • The new methodology provides a viable alternative to the limited exponential model.

Conclusions:

  • The developed parametric cure model approach offers an improved framework for designing single-arm phase II survival trials.
  • This research fills a critical gap in the literature, providing practical tools for trial designers.