ArticleJournal of the Royal Statistical Society. Series C, Applied statistics2016
A dose-schedule finding design for phase I-II clinical trials.
Article in Journal of the Royal Statistical Society. Series C, Applied statistics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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
12 citing papers in PubMed.
- A Biomarker-Based Dose-Schedule Optimization Design for Immunotherapy Trials.Statistics in medicine · 2026Article
- A Bayesian pharmacokinetics integrated phase I-II design to optimize dose-schedule regimes.Biostatistics (Oxford, England) · 2025Article
- Adaptive phase I-II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies.Clinical trials (London, England) · 2024Review
- Novel Clinical Trial Designs with Dose Optimization to Improve Long-term Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Review
- A clinical phase I dose-finding design with adaptive shrinking boundaries for drug combination trials.BMC medical research methodology · 2023Article
- Optimizing dose-schedule regimens with bayesian adaptive designs: opportunities and challenges.Frontiers in pharmacology · 2023Review
- Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics.Biometrics · 2022Article
- Comparison of Phase I-II designs with parametric or semi-parametric models using two different risk-benefit trade-off criteria.Contemporary clinical trials · 2020Article
- Article
- Phase I-II clinical trial design: a state-of-the-art paradigm for dose finding.Annals of oncology : official journal of the European Society for Medical Oncology · 2018Article
- Designs for phase I trials in ordered groups.Statistics in medicine · 2017Article
- A robust Bayesian dose-finding design for phase I/II clinical trials.Biostatistics (Oxford, England) · 2016Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Dose-finding methods aiming at identifying an optimal dose of a treatment with a given schedule may be at a risk of misidentifying the best treatment for patients. In this article we propose a phase I/II clinical trial design to find the optimal dose-schedule combination. We define schedule as the method and timing of administration of a given total dose in a treatment cycle. We propose a Bayesian dynamic model for the joint effects of dose and schedule. The proposed model allows us to borrow strength across dose-schedule combinations without making overly restrictive assumptions on the ordering pattern of the schedule effects. We develop a dose-schedule-finding algorithm to sequentially allocate patients to a desirable dose-schedule combination, and select an optimal combination at the end of the trial. We apply the proposed design to a phase I/II clinical trial of a
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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.