Using time-to-event analysis methodology requires careful
definition of the event, censored observation, provision of
adequate follow-up, number of events, and independence or
"noninformativeness" of the censoring mechanisms relative to the
event. Design and Analysis of Clinical Trials with Time-to-Event
Endpoints provides a thorough presentation of the design,
monitoring, analysis, and interpretation of clinical trials in
which time-to-event is of critical interest. After reviewing
time-to-event endpoint methodology, clinical trial issues, and the
design and monitoring of clinical trials, the book focuses on
inferential analysis methods, including parametric, semiparametric,
categorical, and Bayesian methods; an alternative to the Cox model
for small samples; and estimation and testing for change in hazard.
It then presents descriptive and graphical methods useful in the
analysis of time-to-event endpoints. The next several chapters
explore a variety of clinical trials, from analgesic, antibiotic,
and antiviral trials to cardiovascular and cancer prevention,
prostate cancer, astrocytoma brain tumor, and chronic myelogonous
leukemia trials. The book then covers areas of drug development,
medical practice, and safety assessment. It concludes with the
design and analysis of clinical trials of animals required by the
FDA for new drug applications. Drawing on the expert contributors'
experiences working in biomedical research and clinical drug
development, this comprehensive resource covers an array of
time-to-event methods and explores an assortment of real-world
applications.
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