Design and Analysis of Clinical Trials with Time-to-Event Endpoints

Design and Analysis of Clinical Trials with Time-to-Event Endpoints

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by Karl E. Peace
     
 

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

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Overview

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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Product Details

ISBN-13:
9781420066395
Publisher:
Taylor & Francis
Publication date:
04/22/2009
Series:
Chapman & Hall/CRC Biostatistics Series, #31
Pages:
616
Product dimensions:
6.40(w) x 9.30(h) x 1.50(d)

Related Subjects

Table of Contents

Overview of Time-to-Event Endpoint Methodology Karl E. Peace

Design (and Monitoring) of Clinical Trials with Time-to-Event Endpoints Michael W. Sill and Larry Rubinstein

Overview of Time-to-Event Parametric Methods Karl E. Peace and Kao-Tai Tsai

Overview of Semiparametric Inferential Methods for Time-to-Event Endpoints Jianwen Cai and Donglin Zeng

Overview of Inferential Methods for Categorical Time-to-Event Data Eric V. Slud

Overview of Bayesian Inferential Methods Including Time-to-Event Endpoints Laura H. Gunn

An Efficient Alternative to the Cox Model for Small Time-to-Event Trials Devan V. Mehrotra and Arthur J. Roth

Estimation and Testing for Change in Hazard for Time-to-Event Endpoints Rafia Bhore and Mohammad Huque

Overview of Descriptive and Graphical Methods for Time-to-Event Data Michael O’Connell and Bob Treder

Design and Analysis of Analgesic Trials Akiko Okamoto, Julia Wang, and Surya Mohanty

Design and Analysis of Analgesic Trials with Paired Time-to-Event Endpoints Zhu Wang and Hon Keung Tony Ng

Time-to-Event Endpoint Methods in Antibiotic Trials Karl E. Peace

Design and Analysis of Cardiovascular Prevention Trials Michelle McNabb and Andreas Sashegyi

Design and Analysis of Antiviral Trials Anthony C. Segreti and Lynn P. Dix

Cure Rate Models with Applications to Melanoma and Prostate Cancer Data Ming-Hui Chen and Sungduk Kim

Parametric Likelihoods for Multiple Nonfatal Competing Risks and Death, with Application to Cancer Data Peter F. Thall and Xuemei Wang

Design, Summarization, Analysis, and Interpretation of Cancer Prevention Trials Matthew C. Somerville, Jennifer B. Shannon, and Timothy H. Wilson

LASSO Method in Variable Selection for Right-Censored Time-to-Event Data with Application to Astrocytoma Brain Tumor and Chronic Myelogenous Leukemia Lili Yu and Dennis Pearl

Selecting Optimal Treatments Based on Predictive Factors Eric C. Polley and Mark J. van der Laan

Application of Time-to-Event Methods in the Assessment of Safety in Clinical Trials Kelly L. Moore and Mark J. van der Laan

Design and Analysis of Chronic Carcinogenicity Studies of Pharmaceuticals in Rodents Mohammad Atiar Rahman and Karl K. Lin

Design and Analysis of Time-to-Tumor Response in Animal Studies: A Bayesian Perspective Steve Thomson and Karl K. Lin

Index

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