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Decision theoretic designs for phase II clinical trials with multiple outcomes.

N Stallard1, P F Thall, J Whitehead

  • 1Medical and Pharmaceutical Statistics Research Unit, The University of Reading, Earley Gate, UK. n.stallard@reading.ac.uk

Biometrics
|April 21, 2001
PubMed
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This study introduces a Bayesian decision theory approach for designing phase II clinical trials, balancing treatment efficacy and patient safety. The method optimizes trial design by considering patient outcomes, treatment promise, and trial costs for better decision-making.

Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Decision Science

Background:

  • Phase II clinical trials require evaluating both treatment efficacy and safety.
  • Existing phase II designs often lack a decision-theoretic foundation for handling multiple outcomes.
  • There is a need for a principled approach to construct phase II designs considering various factors.

Purpose of the Study:

  • To develop a Bayesian decision theoretic strategy for constructing phase II clinical trial designs.
  • To incorporate both efficacy and safety (adverse events) into the design framework.
  • To provide a flexible strategy applicable to various clinical settings.

Main Methods:

  • A Bayesian decision theory framework was employed.
  • A gain function was defined, including utilities for patient outcomes, reward for promising treatment declaration, and costs for phase II and phase III trials.

Related Experiment Videos

  • Methods for eliciting gain function parameters and evaluating frequentist operating characteristics were described.

    • Main Results:

    • A novel strategy for phase II design construction based on decision theory was presented.
    • The gain function effectively balances efficacy, safety, and economic considerations.
    • The strategy was successfully illustrated using a peripheral blood stem cell transplantation trial for multiple myeloma.

    Conclusions:

    • The proposed Bayesian decision theoretic strategy offers a robust method for phase II clinical trial design.
    • This approach allows for a more informed and optimized decision-making process in early-phase drug development.
    • The framework provides a valuable tool for researchers designing clinical trials with multiple objectives.