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April 21, 2026Pharmaceutical Statistics

A Seamless Two‐Stage Phase I/ II Trial Design With Backfill and Joint Monitoring for Dose Optimization

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Authors

KTKentaro TakedaJZJing ZhuBYBelay B. Yimer

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Overview

A two-stage trial design demonstrates efficient dose optimization in oncology, highlighting improved patient safety.

Key Points

  • The study aims to create a trial design that effectively optimizes drug dosing while ensuring patient safety and treatment efficacy.
  • Proposes a seamless two-stage Phase I/II trial design
  • Utilizes a dose-finding approach with patient backfilling and Bayesian optimal boundaries
  • Implements joint monitoring of efficacy and toxicity outcomes in Stage 2
  • Simulation studies show superior operating characteristics of the proposed design compared to traditional methods
  • The design allows for early decision-making, improving trial efficiency
  • Explicit control of Type I error rates enhances the safety of patient treatments

Cite This Study

Takeda et al. (2026) studied this question.

synapsesocial.com/papers/69e713decb99343efc98d473https://doi.org/10.1002/pst.70092
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A Seamless Phase II/III Design with Dose Optimization for Oncology Drug Development2024
  2. 2A robust Bayesian dose optimization design with backfill and randomization for phase I/II clinical trials2025
  3. 3A seamless phase II/III design with dose optimization for oncology drug development2024 · 1 citations
  4. 4A Bayesian design with efficient backfilling and expansion to accelerate phase I/II trials accommodating late-onset competing risk outcomes2026
  5. 5M-DODII: Bayesian dose optimization design for randomized phase II study with multiple indications2025 · 1 citations