Design and Analysis of Clinical Trials with Time-to-Event Endpoints Kindle Edition Pdf Download

Design and Analysis of Clinical Trials with Time-to-Event Endpoints (Chapman & Hall/CRC Biostatistics Series) [Print Replica] Kindle Edition
Author: Karl E. Peace ID: B008KZUDGI

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File Size: 10650 KBPrint Length: 616 pagesPublisher: CRC Press; 1 edition (April 23, 2009)Publication Date: April 23, 2009 Sold by:  Digital Services, Inc. Language: EnglishID: B008KZUDGIText-to-Speech: Not enabled X-Ray: Not Enabled Word Wise: Not EnabledLending: Not Enabled Enhanced Typesetting: Not Enabled Best Sellers Rank: #2,400,081 Paid in Kindle Store (See Top 100 Paid in Kindle Store) #833 in Kindle Store > Kindle eBooks > Medical eBooks > Pharmacology > Pharmacy #849 in Kindle Store > Kindle eBooks > Medical eBooks > Research #2448 in Kindle Store > Kindle eBooks > Nonfiction > Science > Mathematics > Applied > Probability & Statistics
Often in clinical trials particularly oncology trials time-to-event are the endpoints of primary interest. The endpoint could be time of death, time to remittance, time to recurrence or something else. In the recent RE-LY trial which was a stroke prevention trial the dual primary endpoints were time-to-an-occurrence of stroke and time-to-a-major bleeding episode. It seems almost always the case that the study will involved estimating these parameters based on data the include a lot of right-censoring. So the methods of survival or relaibility analysis come to play an imprtant role. Usually if the events are rare the sample size requirement will be large because power of the test of differences between two groups is dictated by the number of events which then requires large sample size s to achieve the requisite number of events. The RE-LY trial was a noninferiority trial with three equal size treatment arms and rare event occurrences. So thid trial required approximately 18000 subjects with 600 in each group. Such trials are long, difficult to administer and very expensive. So often the time-to-event endpoint is replaced by a surrogate endpoint.

Karl Peace has edited and contributed to a very timely volume on the design and analysis of time-to-event endpoints in clinical trials. This book can serve as a text or a reference for biostatisticians and particularly those involved in clinical trials, especially oncology trials. A number of authors with a lot of experience with such trials were chosen to contribute to this volume. The first 6 chapters are introductory and mostly overviews of a particular methodology. Chapter 1 by Peace,is a general overview of the topic and an introdcution to what is included in the remaining chapters.
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