Introduction to Statistical Methods for Clinical Trials (Chapman & Hall/CRC Texts in Statistical Science) [Print Replica] [Kindle Edition]
Author: | Language: English | ISBN: B006ORPD0K | Format: PDF, EPUB
Introduction to Statistical Methods for Clinical Trials
Download for free books Introduction to Statistical Methods for Clinical Trials (Chapman & Hall/CRC Texts in Statistical Science) [Print Replica] [Kindle Edition] for everyone book with Mediafire Link Download Link Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials. Direct download links available for Introduction to Statistical Methods for Clinical Trials
Download for free books Introduction to Statistical Methods for Clinical Trials (Chapman & Hall/CRC Texts in Statistical Science) [Print Replica] [Kindle Edition] for everyone book with Mediafire Link Download Link Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials. Direct download links available for Introduction to Statistical Methods for Clinical Trials
- File Size: 7108 KB
- Print Length: 464 pages
- Publisher: Chapman and Hall/CRC; 1 edition (October 3, 2011)
- Sold by: Amazon Digital Services, Inc.
- Language: English
- ASIN: B006ORPD0K
- Text-to-Speech: Not enabled
- Lending: Not Enabled
- Amazon Best Sellers Rank: #899,397 Paid in Kindle Store (See Top 100 Paid in Kindle Store)
The author are very accomplished statisticians with many years of clinical trial experience and research. DeMets along with Gordon Lan is famous for the alpha spending function approach that allowed added flexibility to group sequential trials. In addition to authoring several chapters of the book, Cook and Demets edited the book and invited other prominent researchers to contribute to the chapters. The other contributors are Robin Bechhofer, T. Charles Casper, Richard Chappell, Jens Eickhoff, Jan Feyzi, Marian Fisher, Kyungmann Kim, Rebecca Koscik, Mary Lindstrom, and Ellen Roecker.
The book covers a wide variety of topics and starts from the basics. But although some people equate introductory in a title to mean elementary that would be a wrong conclusion in this case. Many of the topics are advanced and involve state-of-the-art methodology. The area of adaptive designs is, for example, a very hot topic these days and is the subject of a great deal of research.
The chapters are very well written and include most of the crucial topics that come up in trial design and development. For example, in the first chapter randomization is discussed in detail as are issues of trial organization, ethical issues, the reasons why randomized clinical trials are important and some regulatory issues.
Chapter 2 covers problem definition, composite outcomes and the use of surrogate endpoints. Chapter 3 covers trial design for all phases of clinical trials and includes sections on early phase trials, phase III trials and the phase IV postmarketing trials. Methodology includes non-inferiority, screening , prevention, therapeutic and adaptive designs.
Chapter 4 deals with the important issue of sample size determination primarily using frequentist approaches.
No comments:
Post a Comment