Phase 0 clinical trials: Recommendations from the task force on methodology for the development of innovative cancer therapies

被引：33

作者：

Kummar, Shivaani ^{[2
]}

Doroshow, James H. ^{[2
,3
]}

Tomaszewski, Joseph E. ^{[3
]}

Calvert, A. Hilary ^{[4
]}

Lobbezoo, Marinus ^{[5
]}

Giaccone, Giuseppe ^{[1
]}

机构：

[1] NCI, Med Oncol Branch, CCR, NIH, Bethesda, MD 20892 USA

[2] NCI, Ctr Canc Res, Bethesda, MD 20892 USA

[3] NCI, Div Canc Treatment & Diag, Bethesda, MD 20892 USA

[4] No Inst Canc Res, Sch Med, Newcastle Upon Tyne, Tyne & Wear, England

[5] NDDO Res Fdn, Amsterdam, Netherlands

来源：

EUROPEAN JOURNAL OF CANCER | 2009年 / 45卷 / 05期

关键词：

Clinical trials; Phase; 0; Drug development; Oncology; MDICT; TARGETED ANTICANCER THERAPY; I ONCOLOGY TRIALS; DRUG DEVELOPMENT; BIOMARKERS; DESIGN; MDICT;

D O I：

10.1016/j.ejca.2008.10.024

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force has been established as an expert forum to develop practical guidance on the development of innovative anticancer agents, in particular targeted agents. The task force recently addressed the utility, design and application of Phase 0 clinical trials in anticancer drug development. It was concluded that the role of non-therapeutic Phase 0 trials is controversial for several reasons, including the lack of clinical benefit for participating patients. However, it was recognised that Phase 0 trials provide an opportunity to generate essential human pharmacokinetic and pharmacodynamic data earlier in the drug development process, which could be a major advantage in the design and decision making concerning further clinical development of an agent. Construction of a 'decision chart' was highly recommended to assist investigators and sponsors in determining whether an agent is suitable for evaluation in a Phase 0 trial. Published by Elsevier Ltd.

引用

页码：741 / 746

页数：6

共 25 条

[1]

[Anonymous], 2006, BIOTECHNOL LAW REP, DOI DOI 10.1126/scitranslmed.aai7786

[2] Influence of unrecognized molecular heterogeneity on randomized clinical trials [J].