ArticleStatistics in medicine2019
A Bayesian design for phase I cancer therapeutic vaccine trials.
Article in Statistics in medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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
6 citing papers in PubMed.
- Bayesian adaptive model selection design for optimal biological dose finding in phase I/II clinical trials.Biostatistics (Oxford, England) · 2023Trial
- A Biomarker-Based Dose-Schedule Optimization Design for Immunotherapy Trials.Statistics in medicine · 2026Article
- A Novel Adaptive Design Approach for Early-Phase Clinical Trials to Optimize Vaccine Dosage.China CDC weekly · 2025Article
- BIPSE: A biomarker-based phase I/II design for immunotherapy trials with progression-free survival endpoint.Statistics in medicine · 2022Article
- Article
- Tailoring early-phase clinical trial design to address multiple research objectives.Cancer immunology, immunotherapy : CII · 2020Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Phase I clinical trials are the first step in drug development to test a new drug or drug combination on humans. Typical designs of Phase I trials use toxicity as the primary endpoint and aim to find the maximum tolerable dosage. However, these designs are poorly applicable for the development of cancer therapeutic vaccines because the expected safety concerns for these vaccines are not as much as cytotoxic agents. The primary objectives of a cancer therapeutic vaccine phase I trial thus often include determining whether the vaccine shows biologic activity and the minimum dose necessary to achieve a full immune or even clinical response. In this paper, we propose a new Bayesian phase I trial design that allows simultaneous evaluation of safety and immunogenicity outcomes. We demonstrate the proposed clinical trial design by both a numeric study and a therapeutic human papillomavirus vaccine trial.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.