ArticleContemporary clinical trials communications2022
Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial.
Article in Contemporary clinical trials communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed.
- A short review of dose-finding adaptive trial designs for clinical pharmacologists and non-statisticians in oncology.European journal of clinical pharmacology · 2026Review
- Advancing drug development with "Fit-for-Purpose" modeling informed approaches.Journal of pharmacokinetics and pharmacodynamics · 2025Review
- Moving the needle for oncology dose optimization: A call for action.Clinical and translational science · 2024Article
- Moving the needle for oncology dose optimization: A call for action.CPT: pharmacometrics & systems pharmacology · 2024Article
- An extended Bayesian semi-mechanistic dose-finding design for phase I oncology trials using pharmacokinetic and pharmacodynamic information.Statistics in medicine · 2024Article
- Early phase clinical trials in oncology: Realising the potential of seamless designs.European journal of cancer (Oxford, England : 1990) · 2023Article
- Early Phase Dose-Finding Designs for CAR-T Cell Therapies.Pharmaceutical statisticsArticle
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Authors and funding
5 authors.
Funding
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Abstract
backgroundEscalation With Overdose Control (EWOC) designs are increasingly used to ensure dose-toxicity curve of investigational oncology drugs is efficiently characterized during dose escalation steps. We propose a novel EWOC-based method that integrates the longitudinal pharmacokinetic (PK) data of individual patients in a Bayesian forecasting exposure-safety framework.
methodsThe method, called exposure-driven EWOC (ED-EWOC), relies on a population PK model coupled with a Bayesian logistic regression model to make dose recommendation for the next cohort of patients.
resultsWe applied ED-EWOC to a real oncology clinical trial in parallel to a traditional EWOC approach. We found that for comparable priors, ED-EWOC dose recommendations were equivalent to the one suggested by EWOC when PK is dose proportional with low inter-individual variability.
conclusionThis case example demonstrates that ED-EWOC is logistically feasible during a trial conduct when PK bioanalysis can be expedited in the dose escalation phase. Overall, we anticipate that exposure-guided Bayesian designs could benefit patients and drug developers to identify the optimal dose steps of novel compounds entering the clinic with suspected liability in PK or that exhibit large inter-individual variability.
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