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Exploratory thoughts on clinical trials with utilities

S B Tan¹, A F Smith

¹Department of Mathematics, Imperial College of Science, Technology & Medicine, London, U.K.

Statistics in Medicine

|January 9, 1999

Summary

This study optimizes clinical trial design by incorporating patient utility for benefits and side effects. It balances scientific and ethical considerations for better sample size and allocation strategies.

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Area of Science:

Biostatistics
Clinical Trial Design
Decision Analysis

Background:

Clinical trial design often overlooks explicit patient utility values.
Balancing benefits, side effects, and scientific/ethical concerns is complex.

Purpose of the Study:

To develop methods for sample size and allocation in clinical trials using explicit utility functions.
To integrate patient preferences and ethical considerations into trial design.

Main Methods:

Formulating utility functions that quantify benefits, side effects, and their trade-offs.
Applying decision-analytic frameworks to optimize sample size and resource allocation.

Main Results:

Demonstrated a framework for utility-based sample size determination.
Showcased methods for allocating resources considering scientific and ethical trade-offs.

Conclusions:

Explicitly incorporating utility functions enhances clinical trial design.
This approach leads to more ethically sound and scientifically efficient trials.

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