期刊
CONTEMPORARY CLINICAL TRIALS
卷 45, 期 -, 页码 426-434出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.09.019
关键词
3+3; Bayesian design; CRM; mTPI; Next-generation dose finding; Webtool
资金
- NIH [2R01 CA132897-06]
In the past 25 years, the 3 + 3 design has been the most popular approach for planning phase! dose-finding trials in oncology. During the same time period, major development of more efficient model-based designs has been made by statistical researchers aiming to improve the clinical practice of dose finding in oncology. Despite the effort, 3 + 3 is still the most frequently used designs in practice. Part of the reason is due to the lack of software tools that allow comparison of different designs, including 3 + 3 and other model-based methods, in a head-to-head and easy-to-use fashion. To this end, we introduce NextGen-DF, a next-generation tool for designing oncology dose-finding trials that allows for construction, comparison, and calibration of multiple designs via internet, in real time, and independent of computer operating systems. Through NextGen-DF, we present massive and user-generated comparison results based on over 4 million simulated trials, which clearly indicate the inferiority of 3 + 3. To our knowledge, the reported crowd-sourcing results are the largest and most objective comparison across major dose-finding methods to date. NextGen-DF is expected to improve patient care and drug development by providing safer and more efficient designs for phase I oncology trials. NextGen-DF is available at www.compgenome.org/NGDF. (C) 2015 Elsevier Inc. All rights reserved.
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