Dose finding with escalation with overdose control (EWOC) in cancer clinical trials
From MaRDI portal
Publication:903293
DOI10.1214/10-STS333zbMATH Open1328.62598arXiv1011.6479OpenAlexW2952060368MaRDI QIDQ903293FDOQ903293
Authors: Mourad Tighiouart, André Rogatko 
Publication date: 5 January 2016
Published in: Statistical Science (Search for Journal in Brave)
Abstract: Traditionally, the major objective in phase I trials is to identify a working-dose for subsequent studies, whereas the major endpoint in phase II and III trials is treatment efficacy. The dose sought is typically referred to as the maximum tolerated dose (MTD). Several statistical methodologies have been proposed to select the MTD in cancer phase I trials. In this manuscript, we focus on a Bayesian adaptive design, known as escalation with overdose control (EWOC). Several aspects of this design are discussed, including large sample properties of the sequence of doses selected in the trial, choice of prior distributions, and use of covariates. The methodology is exemplified with real-life examples of cancer phase I trials. In particular, we show in the recently completed ABR-217620 (naptumomab estafenatox) trial that omitting an important predictor of toxicity when dose assignments to cancer patients are determined results in a high percent of patients experiencing severe side effects and a significant proportion treated at sub-optimal doses.
Full work available at URL: https://arxiv.org/abs/1011.6479
Recommendations
- Escalation with overdose control using ordinal toxicity grades for cancer phase I clinical trials
- Number of patients per cohort and sample size considerations using dose escalation with overdose control
- Incorporating a patient dichotomous characteristic in cancer phase I clinical trials using escalation with overdose control
- Incoherent dose-escalation in phase I trials using the escalation with overdose control approach
- Unifying CRM and EWOC designs for phase I cancer clinical trials
cancer phase I trialsdose-limiting toxicityescalation with overdose controloptimal Bayesian feasibletolerated dose
Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50) Bayesian problems; characterization of Bayes procedures (62C10)
Cites Work
- Title not available (Why is that?)
- Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer
- Coherence principles in dose-finding studies
- Sequential Designs for Phase I Clinical Trials with Late‐Onset Toxicities
- Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials
- Dose finding in drug development.
- TWO-SAMPLE CONTINUAL REASSESSMENT METHOD
- Optimal Bayesian-feasible dose escalation for cancer phase I trials
- Unifying CRM and EWOC designs for phase I cancer clinical trials
Cited In (17)
- A new design of the continual reassessment method
- A Bayesian adaptive design for dual-agent phase I-II oncology trials integrating efficacy data across stages
- A Bayesian design for phase I cancer therapeutic vaccine trials
- A continual reassessment method without undue risk of toxicity
- Unifying CRM and EWOC designs for phase I cancer clinical trials
- Incorporating a patient dichotomous characteristic in cancer phase I clinical trials using escalation with overdose control
- Incoherent dose-escalation in phase I trials using the escalation with overdose control approach
- A nonparametric Bayesian method for dose finding in drug combinations cancer trials
- Improving safety of the continual reassessment method via a modified allocation rule
- Methodology and application of adaptive and sequential approaches in contemporary clinical trials
- Number of patients per cohort and sample size considerations using dose escalation with overdose control
- Extending the continual reassessment method to accommodate step-up dosing in phase I trials
- Bayesian optimization design for finding a maximum tolerated dose combination in phase I clinical trials
- Adaptive clinical trial designs for phase I cancer studies
- Escalation with overdose control using ordinal toxicity grades for cancer phase I clinical trials
- Stochastic approximation and modern model-based designs for dose-finding clinical trials
- A Bayesian adaptive design in cancer phase I trials using dose combinations in the presence of a baseline covariate
Uses Software
This page was built for publication: Dose finding with escalation with overdose control (EWOC) in cancer clinical trials
Report a bug (only for logged in users!)Click here to report a bug for this page (MaRDI item Q903293)
