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Design of oncology clinical trials: A review
被引:14
|作者:
Ananthakrishnan, Revathi
Menon, Sandeep
机构:
[1] #3 Cambridge, MA 02138
[2] #1 Newton, MA 02460, One Townhouse Drive
关键词:
Phases I;
II and III oncology clinical trials;
Trial designs;
Safety and efficacy endpoints;
PK/PD modeling;
Statistical analyses;
CONTINUAL REASSESSMENT METHOD;
RESPONSE EVALUATION CRITERIA;
ANTIBODY-DRUG CONJUGATE;
TOXICITY TRADE-OFFS;
PRACTICAL CONSIDERATIONS;
TRASTUZUMAB EMTANSINE;
HYPOTHESES SELECTION;
INTERIM ANALYSES;
DOSE-ESCALATION;
2-STAGE DESIGNS;
D O I:
10.1016/j.critrevonc.2013.03.007
中图分类号:
R73 [肿瘤学];
学科分类号:
100214 ;
摘要:
Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This-review focuses on statistical considerations in the design and analysis of oncology clinical trials. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
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页码:144 / 153
页数:10
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