Role of Phase 0 trials in drug development

被引：3
|
作者：
Doroshow, James H. [1 ]
Kummar, Shivaani [2 ]
机构：
[1] NCI, Div Canc Treatment & Diag, NIH, Bethesda, MD 20892 USA
[2] NCI, Med Oncol Branch, Ctr Canc Res, NIH, Bethesda, MD 20892 USA
来源：
FUTURE MEDICINAL CHEMISTRY | 2009年 / 1卷 / 08期
关键词：
ADP-RIBOSE POLYMERASE; CLINICAL-TRIALS; POLY(ADP-RIBOSE) POLYMERASE; CHEMOPREVENTION; INHIBITOR; ABT-888; FDA;
D O I：
10.4155/FMC.09.117
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
Phase 0 trials can provide proof of concept that an agent modulates its intended target without exposing patients to the drug-tolerability testing that precedes efficacy evaluation. Drugs that do not modulate their targets can be discarded, focusing development resources on the most clinically promising agents. However, wider uptake of Phase 0 trials may be hindered by ethical concerns over their lack of therapeutic intent, the substantial resources required to develop and validate target assays or skepticism that such trials save development time.
引用
收藏
页码：1375 / 1380
页数：6
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