RESEARCH ARTICLE


Interactive Software “Isotonic Design using Normalized Equivalent Toxicity Score (ID-NETS©TM)” for Cancer Phase I Clinical Trials



Zhengjia Chen1, 2, *, Zhibo Wang 2, Haibin Wang 3, Taofeek K Owonikoko 4, Jeanne Kowalski 1, 2, Fadlo R Khuri 4
1 Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA 30322, USA
2 Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute, GA 30322, USA
3 Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA
4 Department of Hematology and Medical Oncology, Emory University, Atlanta, GA 30322, USA


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© Chen et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the 1365-B Clifton Rd, Room B4109, Winship Cancer Institute, Emory University, Atlanta, GA 30322, USA; Tel: (404) 778-2017; Fax: (404) 778-5016; E-mail: zchen38@emory.edu


Abstract

Isotonic Design using Normalized Equivalent Toxicity Score (ID-NETS) is a novel Phase I design that integrates the novel toxicity scoring system originally proposed by Chen et al. [1] and the original Isotonic Design proposed by Leung et al. [2]. ID-NETS has substantially improved the accuracy of maximum tolerated dose (MTD) estimation and trial efficiency in the Phase I clinical trial setting by fully utilizing all toxicities experienced by each patient and treating toxicity response as a quasi-continuous variable instead of a binary indicator of dose limiting toxicity (DLT). To facilitate the incorporation of the ID-NETS method into the design and conduct of Phase I clinical trials, we have designed and developed a user-friendly software, ID-NETS©TM, which has two functions: 1) Calculating the recommended dose for the subsequent patient cohort using available completed data; and 2) Performing simulations to obtain the operating characteristics of a trial designed with ID-NETS. Currently, ID-NETS©TMv1.0 is available for free download at (http://winshipbbisr.emory.edu/IDNETS.html).

Keywords: Isotonic design, normalized equivalent toxicity score, maximum tolerated dose, dose limiting toxicity, cancer phase I clinical trial, software.