Continuous endpoints in Bayesian two-stage designs

被引：1

作者：

Brutti, Pierpaolo ^{[1
]}

De Santis, Fulvio ^{[1
]}

Gubbiotti, Stefania ^{[1
]}

Sambucini, Valeria ^{[1
]}

机构：

[1] Sapienza Univ Roma, Dipartimento Sci Stat, Piazzale Aldo Moro 5, I-00182 Rome, Italy

来源：

JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2016年 / 26卷 / 05期

关键词：

Analysis prior; Design prior; Sample size determination; Skew normal distribution; SAMPLE-SIZE DETERMINATION; II CLINICAL-TRIALS; PHASE-II; CONTINUOUS OUTCOMES; CANCER; MODEL;

D O I：

10.1080/10543406.2016.1148719

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Single-arm two-stage designs for phase II of clinical trials typically focus on a binary endpoint obtained by dichotomizing an underlying continuous measure of treatment efficacy. To avoid the resulting loss of information, we propose a two-stage design based on a Bayesian predictive approach that directly uses the original continuous endpoint. Numerical results are provided with reference to phase II cancer trials aimed at assessing tumor shrinking effect of an experimental treatment.

引用

页码：966 / 977

页数：12

共 50 条

[1] Curtailed two-stage designs with two dependent binary endpoints
Chen, Chia-Min
Chi, Yunchan
[J]. PHARMACEUTICAL STATISTICS, 2012, 11 (01) : 57 - 62
[2] A Bayesian two-stage group sequential scheme for ordinal endpoints
Zhong, Chengxue
Miao, Hongyu
Pan, Haitao
[J]. JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS, 2023, 72 (03) : 670 - 687
[3] A COMPARISON OF NEW AND EXISTING BAYESIAN TWO-STAGE DESIGNS
Ruggoo, Arvind
Vandebroek, Martina
[J]. SOUTH AFRICAN STATISTICAL JOURNAL, 2009, 43 (02) : 177 - 194
[4] Bayesian two-stage design for drug screening trials with switching hypothesis tests based on continuous endpoints
Sun, Nan
Zhong, Junjiang
We, Miin-Jye
[J]. COMMUNICATIONS IN STATISTICS-THEORY AND METHODS, 2021, 50 (02) : 415 - 431
[5] A two-stage Bayesian model selection strategy for supersaturated designs
Beattie, SD
Fong, DKH
Lin, DKJ
[J]. TECHNOMETRICS, 2002, 44 (01) : 55 - 63
[6] Bayesian two-stage designs for phase II clinical trials
Tan, SB
Machin, D
[J]. STATISTICS IN MEDICINE, 2002, 21 (14) : 1991 - 2012
[7] Bayesian two-stage designs for phase II clinical trials
Tan, S. B.
Machin, D.
[J]. STATISTICS IN MEDICINE, 2006, 25 (19) : 3407 - 3408
[8] Optimal Two-Stage Phase II Designs with Long-Term Endpoints
Huang, Bo
Talukder, Enayet
Thomas, Neal
[J]. STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2010, 2 (01): : 51 - 61
[9] A Two-Stage Design for Drug Screening Trials Based on Continuous Endpoints
Hsiao-Hui Tsou
Chin-Fu Hsiao
Shein-Chung Chow
Jen-pei Liu
[J]. Drug information journal : DIJ / Drug Information Association, 2008, 42 (3): : 253 - 262
[10] A two-stage design for drug screening trials based on continuous endpoints
Tsou, Hslao-Hui
Hsiao, Chin-Fu
Chow, Shein-Chung
Liu, Jen-pei
[J]. DRUG INFORMATION JOURNAL, 2008, 42 (03): : 253 - 262

← 1 2 3 4 5 →