Phases 0, 1 and 2 oncology clinical trials: current questions

被引：3

作者：

Penel, N. ^{[1
,2
]}

Fournier, C. ^{[3
]}

Stephanie, C. ^{[4
]}

机构：

[1] Ctr Oscar Lambret, Dept Cancerol Gen, F-59000 Lille, France

[2] Univ Lille 2, EA Sante Publ Epidemiol & Modelisat Malad Chron 2, F-59000 Lille, France

[3] Ctr Oscar Lambret, Unite Biostat, F-59000 Lille, France

[4] Ctr Oscar Lambret, Unite Integree Rech Clin, F-59000 Lille, France

来源：

BULLETIN DU CANCER | 2010年 / 97卷 / 01期

关键词：

exploratory trials; methodology; randomization; stratification; patient selection; RESPONSE EVALUATION CRITERIA; II TRIALS; IMATINIB MESYLATE; BENEFITS; DESIGN; RISKS; PROGRESSION; INHIBITOR; SURVIVAL; THERAPY;

D O I：

10.1684/bdc.2010.1016

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.

引用

页码：55 / 63

页数：9

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