Design and Analysis of Clinical Trials with Time-to-Event Endpoints (Chapman & Hall/CRC Biostatistics Series)

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. Content: 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 / Jianween 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 myelogonous 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. 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 / Jianween Cai and Donling 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 Anefficient 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 H.K. Tony Ng Time-to-event endpoint methods in antibiotic trials / Karl E. Peace None 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 / Matt Somerville, Jennifer Shannon, and Tim Wilson The Lasso method in variable selection for right-censored time-to-event data with application to astrocytoma brain tumor and chronic myelogonous 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.

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.

This resource provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. Incorporating the collaborations of truly world-class statisticians, it discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints. The book presents parametric, semiparametric, categorical, and Bayesian inferential and descriptive methods for analyzing time-to-event endpoints and covers numerous clinical trial .. Provides a presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest. This book discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints.