Peace K.E. (ed.) Design and Analysis of Clinical Trials with Time-to-Event Endpoints

Boca Raton: CRC Press, 2009. — 608 p.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.Overview of time-to-event endpoint methodology
Design (and monitoring) of clinical trials with time-to-event endpoints
Overview of time-to-event parametric methods
Overview of semiparametric inferential methods for time-to-event endpoints
Overview of inferential methods for categorical time-to-event data
Overview of Bayesian inferential methods including time-to-event endpoints
An efficient alternative to the Cox model for small time-to-event trials
Estimation and testing for change in hazard for time-to-event endpoints
Overview of descriptive and graphical methods for time-to-event data
Design and analysis of analgesic trials
Design and analysis of analgesic trials with paired time-to-event endpoints
Time-to-event endpoint methods in antibiotic trials
Design and analysis of cardiovascular prevention trials
Design and analysis of antiviral trials
Cure rate models with applications to melanoma and prostate cancer data
Parametric likelihoods for multiple nonfatal competing risks and death, with application to cancer data
Design, summarization, analysis, and interpretation of cancer prevention trials
LASSO method in variable selection for right-censored time-to-event data with application to astrocytoma brain tumor and chronic myelogonous leukemia
Selecting optimal treatments based on predictive factors
Application of time-to-event methods in the assessment of safety in clinical trials
Design and analysis of chronic carcinogenicity studies of pharmaceuticals in rodents
Design and analysis of time-to-tumor response in animal studies : a Bayesian perspective