ArticleJournal of biopharmaceutical statistics2015
Seamless Phase I/II Adaptive Design for Oncology Trials of Molecularly Targeted Agents.
Article in Journal of biopharmaceutical statistics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.
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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
33 citing papers in PubMed.
- Bayesian adaptive model selection design for optimal biological dose finding in phase I/II clinical trials.Biostatistics (Oxford, England) · 2023Trial
- Surv-CRM-12: A Bayesian phase I/II survival CRM for right-censored toxicity endpoints with competing disease progression.Statistics in medicine · 2022Trial
- Implementing the EffTox dose-finding design in the Matchpoint trial.BMC medical research methodology · 2017Trial
- A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma.Contemporary clinical trials · 2015Trial
- A review of seamless phase I/II trial designs towards oncology dose optimization with examples of clinical pharmacology considerations in early drug development.European journal of clinical pharmacology · 2026Review
- DOSET: dose optimization with simultaneous efficacy and toxicity evaluation, motivated by a first-in-human phase I CAR T lymphoma trial.ESMO open · 2026Article
- PRO-ADD: Patient-empowered dose-finding trials integrating safety, preliminary efficacy and patient-reported outcomes for optimal dose selection.Statistical methods in medical research · 2026Article
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.Statistics in biopharmaceutical research · 2025Article
- A seamless Phase I/II platform design with a time-to-event efficacy endpoint for potential COVID-19 therapies.Statistical methods in medical research · 2024Article
- REDOMA: Bayesian random-effects dose-optimization meta-analysis using spike-and-slab priors.Statistics in medicine · 2024Article
- Application of the patient-reported outcomes continual reassessment method to a phase I study of radiotherapy in endometrial cancer.The international journal of biostatistics · 2023Article
- Adaptive Phase 1 Design in Radiation Therapy Trials.International journal of radiation oncology, biology, physics · 2022Article
- CFO: Calibration-free odds design for phase I/II clinical trials.Statistical methods in medical research · 2022Article
- Seamless phase I/II design for novel anticancer agents with competing disease progression.Statistics in medicine · 2021Article
- Is more better? An analysis of toxicity and response outcomes from dose-finding clinical trials in cancer.BMC cancer · 2021Article
- Designing Dose-Finding Phase I Clinical Trials: Top 10 Questions That Should Be Discussed With Your Statistician.JCO precision oncology · 2021Article
- Flexible Phase I-II design for partially ordered regimens with application to therapeutic cancer vaccines.Statistics in biosciences · 2020Article
- Master protocols in immuno-oncology: do novel drugs deserve novel designs?Journal for immunotherapy of cancer · 2020Review
- A latent variable model for improving inference in trials assessing the effect of dose on toxicity and composite efficacy endpoints.Statistical methods in medical research · 2020Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
In dose-finding trials of chemotherapeutic agents, the goal of identifying the maximum tolerated dose is usually determined by considering information on toxicity only, with the assumption that the highest safe dose also provides the most promising outlook for efficacy. Trials of molecularly targeted agents challenge accepted dose-finding methods because minimal toxicity may arise over all doses under consideration and higher doses may not result in greater response. In this article, we propose a new early-phase method for trials investigating targeted agents. We provide simulation results illustrating the operating characteristics of our design.
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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.