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Optimal flexible designs in phase II clinical trials

T T Chen¹, T H Ng

¹Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892, USA. tchen@helix.nih.gov

Statistics in Medicine

|November 20, 1998

Summary

This study introduces flexible two-stage designs for phase II cancer trials, applying Simon

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Area of Science:

Clinical Trials Methodology
Biostatistics
Cancer Research

Background:

Phase II cancer clinical trials commonly use two-stage designs to assess drug efficacy.
Simon's optimal and minimax criteria are established benchmarks for these designs.
Practical challenges in cooperative group settings can hinder exact sample size adherence.

Purpose of the Study:

To define and evaluate flexible two-stage designs for phase II cancer trials.
To apply Simon's optimal and minimax criteria to these flexible designs.
To minimize the number of patients exposed to ineffective drugs.

Main Methods:

Explicitly defined flexible designs as collections of two-stage designs with variable first and second stage sizes.
Applied Simon's optimal and minimax criteria to assess these flexible designs.
Focused on minimizing the number of patients tested on ineffective treatments.

Main Results:

Flexible designs offer adaptability in sample size within defined ranges.
Application of Simon's criteria to flexible designs aims to optimize patient allocation.
The proposed approach seeks to enhance efficiency in early-phase cancer drug evaluation.

Conclusions:

Flexible two-stage designs provide a practical approach to phase II cancer trials.
Utilizing Simon's criteria with flexible designs can improve resource allocation.
This methodology aids in efficiently identifying promising cancer therapies.

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