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A Bayesian phase I/II platform design with survival efficacy endpoint for dose optimization.

Xian Shi1, Jiangyan Zhao1, Jin Xu1,2

  • 1School of Statistics, East China Normal University, Shanghai, China.

Statistical Methods in Medical Research
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Summary
This summary is machine-generated.

This study introduces a Bayesian platform design for early-phase drug development, optimizing dose selection by jointly analyzing toxicity and efficacy data across multiple indications.

Keywords:
Bayesian adaptive designoptimal biological doseplatform trialsurvival efficacy endpoint

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacometrics

Background:

  • Traditional drug development is lengthy and costly.
  • Phase I/II trials often evaluate safety and efficacy separately.
  • Co-developing therapies requires efficient dose-finding strategies.

Purpose of the Study:

  • To propose a novel Bayesian phase I/II platform design (BPCT) for co-developing therapies.
  • To jointly model time-to-event efficacy and binary toxicity outcomes.
  • To optimize dose selection and risk-benefit assessment across indications.

Main Methods:

  • Utilized a Bayesian hierarchical framework for information sharing across indications.
  • Jointly modeled binary toxicity and time-to-event efficacy outcomes.
  • Incorporated adaptive dose escalation/de-escalation based on interim data and utility functions.

Main Results:

  • The proposed Bayesian platform design (BPCT) demonstrated desirable operating characteristics in simulations.
  • The design enables efficient information sharing and dose optimization across multiple indications.
  • Simulation studies confirmed flexibility and efficiency in identifying optimal biological doses.

Conclusions:

  • The BPCT offers a flexible and efficient approach for co-developing drugs with time-to-event endpoints.
  • This design can significantly shorten drug development timelines and reduce costs.
  • The approach facilitates expedited regulatory approval by providing robust dose-efficacy and dose-toxicity evidence.