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Using Win Odds to Improve Commit-to-Phase-3 Decision-Making in Oncology.

Benjamin F Hartley1, Thomas Drury2, Brian Di Pace3

  • 1Veramed Ltd., Twickenham, UK.

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|February 14, 2025
PubMed
Summary
This summary is machine-generated.

A new win odds framework improves decisions on committing to phase 3 oncology clinical trials. This method better predicts overall survival outcomes compared to existing approaches.

Keywords:
multi‐state modelphase 2 clinical trialsquantitative decision makingsurrogate endpointswin statistics

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Area of Science:

  • Clinical Trials
  • Oncology
  • Biostatistics

Background:

  • Deciding to advance oncology drugs to phase 3 clinical trials is complex.
  • Understanding relationships between registration endpoints (e.g., overall survival) and surrogate endpoints (e.g., progression-free survival, objective response) is crucial but often limited.

Purpose of the Study:

  • To present a novel decision-making framework for committing to phase 3 oncology trials.
  • To introduce and evaluate the 'three-endpoint win odds' as a metric for improved decision-making.

Main Methods:

  • Developed a decision-making framework based on the three-endpoint win odds.
  • Interpreted win odds as the reciprocal of the average hazard ratio for overall survival.
  • Simulated correlated patient-level oncology endpoints using a multi-state disease model.
  • Validated the method with simulation studies and a clinical trial case study.

Main Results:

  • The win odds framework provides a robust method for decision-making in oncology drug development.
  • Simulation studies confirmed the performance of the win odds method.
  • The multi-state model successfully generated clinically realistic data for analysis.

Conclusions:

  • The win odds framework offers a superior approach to commit-to-phase-3 decisions in oncology compared to existing methods.
  • This framework enhances the understanding and prediction of overall survival based on early clinical trial endpoints.