TEAMS: Toxicity- and Efficacy-Based Dose-Insertion Design with Adaptive Model Selection for Phase I/II Dose-Escalation Trials in Oncology

In many oncology clinical trials it is necessary to insert new candidate doses when the prespecified doses are poorly elicited. Formal statistical designs with dose insertion are lacking. We propose a dose-insertion design for phase I/II clinical trials in oncology based on both efficacy and toxicit...

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Bibliographic Details
Published in:Statistics in biosciences 2015-10, Vol.7 (2), p.432-459
Main Authors: Guo, Wentian, Ni, Yang, Ji, Yuan
Format: Article
Language:English
Subjects:
Biostatistics
Health Sciences
Mathematics and Statistics
Medicine
Statistics
Statistics for Life Sciences
Theoretical Ecology/Statistics
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Summary:In many oncology clinical trials it is necessary to insert new candidate doses when the prespecified doses are poorly elicited. Formal statistical designs with dose insertion are lacking. We propose a dose-insertion design for phase I/II clinical trials in oncology based on both efficacy and toxicity outcomes. We also implement Bayesian model selection during the course of the trial so that better models can be adaptively chosen to achieve more accurate inference. The new design, TEAMS, achieves great operating characteristics in extensive simulation studies due to its ability to adaptively insert new doses as well as perform model selection. As a result, appropriate doses are inserted when necessary and desirable doses are selected with higher probabilities at the end of the trial.
ISSN:1867-1764
1867-1772
DOI:10.1007/s12561-015-9133-9