Adaptive designs for dose-finding based on efficacy-toxicity response

被引：86

作者：

Dragalin, V ^{[1
]}

Fedorov, V ^{[1
]}

机构：

[1] GlaxoSmithKline Inc, BDS, SDS, Res Stat Unit, Collegeville, PA 19426 USA

来源：

JOURNAL OF STATISTICAL PLANNING AND INFERENCE | 2006年 / 136卷 / 06期

关键词：

adaptive design; Cox bivariate binary model; dose-finding; Gumbel logistic regression model; information matrix; optimal experimental design; optimal safe dose; phase I/II clinical trials;

D O I：

10.1016/j.jspi.2005.08.005

中图分类号：

O21 [概率论与数理统计]; C8 [统计学];

学科分类号：

020208 ; 070103 ; 0714 ;

摘要：

We propose a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available. We model the distribution of this bivariate binary endpoint using either Gumbel bivariate logistic regression or Cox bivariate binary model. In both cases, the analytic formulae for the Fisher information matrix are obtained, that form the basis for derivation of the locally optimal and adaptive designs. (c) 2005 Elsevier B.V. All rights reserved.

引用

页码：1800 / 1823

页数：24

共 50 条

[31] Retrospective analysis of sequential dose-finding designs
O'Quigley, J
BIOMETRICS, 2005, 61 (03) : 749 - 756
[32] Adaptive Bayesian Design for Phase I Dose-Finding Trials Using a Joint Model of Response and Toxicity
Wang, Meihua
Day, Roger
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2010, 20 (01) : 125 - 144
[33] A New Statistical Method for Dose-Finding Based on Efficacy and Toxicity in Early Phase Clinical Trials
Peter F. Thall
Elihu H. Estey
Hsi-Guang Sung
Investigational New Drugs, 1999, 17 : 155 - 167
[34] phase1RMD: An R package for repeated measures dose-finding designs with novel toxicity and efficacy endpoints
Yin, Jun
Du, Yu
Qin, Rui
Shen, Shihao
Mandrekar, Sumithra
PLOS ONE, 2021, 16 (09):
[35] A new statistical method for dose-finding based on efficacy and toxicity in early phase clinical trials
Thall, PF
Estey, EH
Sung, HG
INVESTIGATIONAL NEW DRUGS, 1999, 17 (02) : 155 - 167
[36] Adaptive Seamless Dose-Finding Trials
Chen, Ningyuan
Khademi, Amin
M&SOM-MANUFACTURING & SERVICE OPERATIONS MANAGEMENT, 2024, 26 (05) : 1656 - 1673
[37] Novel toxicity endpoint for dose-finding designs evaluating molecularly targeted agents (MTA).
Ezzalfani, Monia
Zohar, Sarah
Mandrekar, Sumithra J.
Vassal, Gilles
Le Deley, Marie-Cecile
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (15)
[38] Proportional odds model for dose-finding clinical trial designs with ordinal toxicity grading
Van Meter, Emily M.
Garrett-Mayer, Elizabeth
Bandyopadhyay, Dipankar
STATISTICS IN MEDICINE, 2011, 30 (17) : 2070 - 2080
[39] Adaptive Dc-optimal designs for dose finding based on a continuous efficacy endpoint
Padmanabhan, S. Krishna
Dragalin, Vladimir
BIOMETRICAL JOURNAL, 2010, 52 (06) : 836 - 852
[40] Probability intervals of toxicity and efficacy design for dose-finding clinical trials in oncology
Lin, Xiaolei
Ji, Yuan
STATISTICAL METHODS IN MEDICAL RESEARCH, 2021, 30 (03) : 843 - 856

← 1 2 3 4 5 →