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Bayesian approach to two-stage phase II trial

P A Pepple¹, S C Choi

¹Department of Mathematical Sciences, Virginia Commonwealth University, Richmond 23284-2014, USA.

Journal of Biopharmaceutical Statistics

|May 1, 1997

Summary

This summary is machine-generated.

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This study introduces a two-stage Bayesian phase II clinical trial design to improve therapeutic agent selection and efficacy assessment. Simulations show this approach is a promising alternative to traditional fixed-sample-size methods.

Area of Science:

Clinical Trials
Biostatistics
Pharmacology

Background:

Inadequate Phase II studies often lead to clinical trial failures.
Selecting the optimal therapeutic agent and assessing its efficacy are critical challenges.

Purpose of the Study:

To propose a two-stage Bayesian phase II clinical trial design.
To enhance the selection of the most effective therapeutic agent.
To improve the assessment of agent efficacy relative to a control group.

Main Methods:

A two-stage Bayesian approach is employed for phase II clinical trials.
The first stage focuses on selecting the best therapeutic agent.
The second stage evaluates the selected agent's efficacy against a control, using an approximate likelihood function.

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Main Results:

A simulation study was conducted to evaluate the Bayesian approach's performance.
The proposed Bayesian method was compared against two fixed-sample-size approaches.
Simulation results indicate the Bayesian approach is a viable alternative.

Conclusions:

The developed two-stage Bayesian phase II design offers an attractive alternative to fixed-sample-size methods.
This approach may reduce the likelihood of negative outcomes in clinical trials.
Further investigation into approximate Bayesian methods for clinical trial design is warranted.