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
Identifiers and Pagination:Year: 2013
First Page: 8
Last Page: 17
Publisher Id: TOMINFOJ-7-8
Article History:Received Date: 12/10/2012
Revision Received Date: 17/1/2013
Acceptance Date: 17/1/2013
Electronic publication date: 5/4/2013
Collection year: 2013
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.
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.  and the original Isotonic Design proposed by Leung et al. . 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).