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Design of oncology clinical trials: A review

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CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
卷 88, 期 1, 页码 144-153

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ELSEVIER SCIENCE INC
DOI: 10.1016/j.critrevonc.2013.03.007

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Phases I; II and III oncology clinical trials; Trial designs; Safety and efficacy endpoints; PK/PD modeling; Statistical analyses

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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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