Cancer Clinical Trials: Current and Controversial Issues in Design
and Analysis provides statisticians with an understanding of the
critical challenges currently encountered in oncology trials.
Well-known statisticians from academic institutions, regulatory and
government agencies (such as the U.S. FDA and National Cancer
Institute), and the pharmaceutical industry share their extensive
experiences in cancer clinical trials and present examples taken
from actual trials. The book covers topics that are often
perplexing and sometimes controversial in cancer clinical trials.
Most of the issues addressed are also important for clinical trials
in other settings. After discussing general topics, the book
focuses on aspects of early and late phase clinical trials. It also
explores personalized medicine, including biomarker-based clinical
trials, adaptive clinical trial designs, and dynamic treatment
regimes.
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