ArticleJournal of biopharmaceutical statistics2026
BOP2-TE: Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity with application to dose optimization.
Article in Journal of biopharmaceutical statistics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- From Phase Ib/II to Seamless Phase II/III: A Simulation-Based Discussion of Design Strategies for Dose Optimization and Confirmatory Phase.Clinical pharmacology and therapeutics · 2026Article
- Information borrowing in phase II randomized dose-ranging clinical trials in oncology.BMC medical research methodology · 2026Article
- Challenging go/no-go decision scenarios and design recommendations in phase II oncology trials.Journal of the National Cancer Center · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
We propose a Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity, referred to as BOP2-TE, to improve the operating characteristics of the BOP2 design proposed by Zhou. BOP2-TE utilizes a Dirichlet-multinomial model to jointly model the distribution of toxicity and efficacy endpoints, making go/no-go decisions based on the posterior probability of toxicity and futility. In comparison to the original BOP2 and other existing designs, BOP2-TE offers the advantage of providing rigorous type I error control in cases where the treatment is toxic and futile, effective but toxic, or safe but futile, while optimizing power when the treatment is effective and safe. As a result, BOP2-TE enhances trial safety and efficacy. We also explore the incorporation of BOP2-TE into multiple-dose randomized trials for dose optimization, and consider a seamless design that integrates phase I dose finding with phase II randomized dose optimization. BOP2-TE is user-friendly, as its decision boundary can be determined prior to the trial's onset. Simulations demonstrate that BOP2-TE possesses desirable operating characteristics. We have developed a user-friendly web application as part of the BOP2 app, which is freely available at https://www.trialdesign.org.
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Registered trials
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