Using Win Odds to Improve Commit-to-Phase-3 Decision-Making in Oncology.

 0 Người đánh giá. Xếp hạng trung bình 0

Tác giả: Tai-Tsang Chen, Brian Di Pace, Thomas Drury, Benjamin F Hartley, Inna Perevozskaya, Helen Zhou

Ngôn ngữ: eng

Ký hiệu phân loại: 920.71 Men

Thông tin xuất bản: England : Statistics in medicine , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 57524

Making good decisions about whether to commit-to-phase 3 clinical trials is challenging. This is especially true in oncology because the relationships between the registration endpoint, overall survival, and endpoints such as progression-free survival and confirmed objective response are often poorly understood. We present a framework for decision-making based on a three-endpoint win odds. We discuss properties of the win odds and suggest that it can be interpreted, for decision-making, as the reciprocal of an average hazard ratio for overall survival. We confirm the performance of the decision-making method using simulation studies and a clinical trial case study. As part of this work, we describe the simulation of correlated patient-level oncology endpoints using a multi-state model of disease. This model can provide clinically realistic data for testing the performance of analysis methods. We conclude that the win odds can improve commit-to-phase-3 decision-making compared with other methods.
Tạo bộ sưu tập với mã QR

THƯ VIỆN - TRƯỜNG ĐẠI HỌC CÔNG NGHỆ TP.HCM

ĐT: (028) 36225755 | Email: tt.thuvien@hutech.edu.vn

Copyright @2024 THƯ VIỆN HUTECH