An integrated dose-finding tool for phase I trials in oncology
Shengjie Yang1, Sue-Jane Wang2, Yuan Ji3
1Program of Computational Genomics & Medicine, Northshore University HealthSystem, USA.
Contemporary Clinical Trials
|October 1, 2015
Summary
The 3+3 design is outdated for phase I oncology trials. New software, NextGen-DF, demonstrates that model-based designs are superior for efficient and safe dose finding.
Area of Science:
- Oncology
- Clinical Trial Design
- Biostatistics
Background:
- The 3+3 design has dominated phase I oncology dose-finding trials for 25 years.
- Despite statistical advancements in model-based designs, the 3+3 design remains prevalent due to a lack of accessible comparison tools.
Purpose of the Study:
- To introduce NextGen-DF, a web-based tool for constructing, comparing, and calibrating oncology dose-finding trial designs.
- To facilitate head-to-head comparisons between the traditional 3+3 design and advanced model-based methods.
Main Methods:
- Development of NextGen-DF, a real-time, cross-platform internet tool for trial design simulation.
- Generation of comparison results from over 4 million simulated trials using NextGen-DF.
Main Results:
- Massive, crowd-sourced simulation data clearly indicate the inferiority of the 3+3 design compared to model-based alternatives.
- The largest and most objective comparison to date across major dose-finding methods has been reported.
Conclusions:
- NextGen-DF provides objective, large-scale evidence to guide the selection of superior dose-finding designs.
- The tool is expected to enhance patient care and drug development by promoting safer and more efficient phase I oncology trials.
