Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
September 10, 2025Statistical Methods in Medical ResearchOpen Access

A robust Bayesian dose optimization design with backfill and randomization for phase I/II clinical trials

View Full Paper
Ask AI
Bookmark
Share

Authors

YQYingjie QiuMLMingyue Li

Discussion

Loading...

Member takes

Overview

Proposed Bayesian design enhances efficacy and safety in phase I clinical trials with backfill cohorts.

Key Points

  • This Bayesian design improves the selection of optimal dosage while addressing toxicity and efficacy.
  • Simulation studies show a reduction in subtherapeutic doses and shorter trial durations.
  • The framework effectively integrates backfill strategies, allowing the enrollment of patients at lower doses.
  • This approach has particular relevance for novel cancer treatments such as targeted therapies and immunotherapies.

Cite This Study

Qiu et al. (2025) studied this question.

synapsesocial.com/papers/68c192459b7b07f3a0616827https://doi.org/10.1177/09622802251374290
View Full Paper
Ask AI
Bookmark
Share

Also Consider

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

  1. 1A Bayesian design with efficient backfilling and expansion to accelerate phase I/II trials accommodating late-onset competing risk outcomes2026
  2. 2A Seamless Two‐Stage Phase I/ <scp>II</scp> Trial Design With Backfill and Joint Monitoring for Dose Optimization2026 · 1 citations
  3. 3Implementing and assessing Bayesian response-adaptive randomisation for backfilling in dose-finding trials2024 · 2 citations
  4. 4Data from Backfilling Patients in Phase I Dose-Escalation Trials Using Bayesian Optimal Interval Design (BOIN)2024
  5. 5M-DODII: Bayesian dose optimization design for randomized phase II study with multiple indications2025 · 1 citations