Design of oncology clinical trials: A review

Abstract 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...

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Bibliographic Details
Published in:Critical reviews in oncology/hematology 2013-10, Vol.88 (1), p.144-153
Main Authors: Ananthakrishnan, Revathi, Menon, Sandeep
Format: Article
Language:English
Subjects:
Clinical Trials as Topic - standards
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Hematology, Oncology and Palliative Medicine
Humans
II and III oncology clinical trials
Neoplasms - drug therapy
Phases I
PK/PD modeling
Research Design - standards
Safety and efficacy endpoints
Statistical analyses
Trial designs
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Summary:Abstract 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.
ISSN:1040-8428
1879-0461
DOI:10.1016/j.critrevonc.2013.03.007