title: Interactive Software "Isotonic Design using Normalized Equivalent Toxicity Score (ID-NETS©TM)" for Cancer Phase I Clinical Trials.
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(©TM)v1.0 is available for free download at http://winshipbbisr.emory.edu/IDNETS.html.
authors.affiliation: Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA 30322, USA ; Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute, GA 30322, USA.
authors.forename: Zhengjia
authors.initials: Z
authors.lastname: Chen
authors.forename: Zhibo
authors.initials: Z
authors.lastname: Wang
authors.forename: Haibin
authors.initials: H
authors.lastname: Wang
authors.forename: Taofeek K
authors.initials: TK
authors.lastname: Owonikoko
authors.forename: Jeanne
authors.initials: J
authors.lastname: Kowalski
authors.forename: Fadlo R
authors.initials: FR
authors.lastname: Khuri
keywords: Isotonic design; cancer phase I clinical trial; dose limiting toxicity; maximum tolerated dose; normalized equivalent toxicity score; software.