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

Hardcover (Print)
Buy New
Buy New from
Used and New from Other Sellers
Used and New from Other Sellers
from $60.93
Usually ships in 1-2 business days
(Save 50%)
Other sellers (Hardcover)
  • All (5) from $60.93   
  • New (4) from $60.93   
  • Used (1) from $103.00   


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.

Read More Show Less

Editorial Reviews

From the Publisher
… One of the strengths of the book is the collection, discussion and illustration of the many diverse time-to-event problems that may occur in practice. … this publication provides a comprehensive overview of classical and emerging ideas in the analysis of time-to-event problems. Written by experts in their area, the book has a wealth of references in each topic should the reader wish to learn about or extend their understanding of individual concepts or analysis methods. It is a worthwhile book to have in the library for anyone working in designing, conducting, analysing or interpreting studies with time-to-event outcomes.
Australian & New Zealand Journal of Statistics, 2011
Read More Show Less

Product Details

Meet the Author

Karl E. Peace is Georgia Cancer Coalition Distinguished Cancer Scholar (GCCDCS), Senior Research Scientist, and Professor of Biostatistics in the Jiann-Ping Hsu College of Public Health (JPHCOPH) at Georgia Southern University. In addition to his many endowments and awards, Dr. Peace has made critical contributions to the development and approval of drugs to treat Alzheimer’s disease, prevent gastrointestinal ulcers, reduce the risk of myocardial infarction, and treat anxiety/depression.

Read More Show Less

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


Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Terms of Use.
  • - Barnes & reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)