An accelerated pathway for targeted cancer therapies

被引：28

作者：

McClellan, Mark ^{[1
]}

Benner, Joshua ^{[1
]}

Schilsky, Richard ^{[2
]}

Epstein, David ^{[3
]}

Woosley, Ray ^{[4
]}

Friend, Stephen ^{[5
]}

Sidransky, David ^{[6
]}

Geoghegan, Cindy ^{[7
]}

Kessler, David ^{[8
]}

机构：

[1] Brookings Inst, Engelberg Ctr Hlth Care Reform, Washington, DC 20036 USA

[2] Univ Chicago, Med Ctr, Chicago, IL 60637 USA

[3] Novartis Pharmaceut, Basel, Switzerland

[4] Crit Path Inst, Tucson, AZ USA

[5] Sage Bionetworks, Seattle, WA USA

[6] Johns Hopkins Univ, Baltimore, MD USA

[7] Patient & Partners LLC, New York, NY USA

[8] Univ Calif San Francisco, San Francisco, CA 94143 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2011年 / 10卷 / 02期

关键词：

CLINICAL-TRIAL DESIGNS;

D O I：

10.1038/nrd3360

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 [微生物学]; 090105 [作物生产系统与生态工程];

摘要：

A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers. © 2011 Macmillan Publishers Limited. All rights reserved.

引用

页码：79 / 80

页数：2

共 7 条

[1]

I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy [J].

Barker, A. D. ;

Sigman, C. C. ;

Kelloff, G. J. ;

Hylton, N. M. ;

Berry, D. A. ;

Esserman, L. J. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) :97-100

[2]

Strategic paths for biomarker qualification [J].

Goodsaid, Federico M. ;

Frueh, Felix W. ;

Mattes, William .

TOXICOLOGY, 2008, 245 (03) :219-223

[3]

Randomized phase III clinical trial designs for targeted agents [J].

Hoering, Antje ;

LeBlanc, Mike ;

Crowley, John J. .

CLINICAL CANCER RESEARCH, 2008, 14 (14) :4358-4367

[4]

Biomarker-adaptive threshold design: A procedure for evaluating treatment with possible biomarker-defined subset effect [J].

Jiang, Wenyu ;

Freidlin, Boris ;

Simon, Richard .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2007, 99 (13) :1036-1043

[5]

Clinical Trial Designs for Predictive Biomarker Validation: Theoretical Considerations and Practical Challenges [J].

Mandrekar, Sumithra J. ;

Sargent, Daniel J. .

JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (24) :4027-4034

[6]

Evaluating the efficiency of targeted designs for randomized clinical trials [J].

Simon, R ;

Maitournam, A .

CLINICAL CANCER RESEARCH, 2004, 10 (20) :6759-6763

[7]

US FDA, 2005, DRUG DIAGN COD CONC

← 1 →