{"product_id":"clinical-trial-design-isbn-9780470581711","title":"Clinical Trial Design","description":"\u003cb\u003eA balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods\u003c\/b\u003e\u003cbr\u003e \u003cbr\u003e   \u003cp\u003eThere has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics.\u003c\/p\u003e \u003cp\u003eRecognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eRisk and benefit analysis for toxicity and efficacy trade-offs\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBayesian predictive probability trial monitoring\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBayesian adaptive randomization\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eLate onset toxicity and response\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDose finding in drug combination trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eTargeted therapy designs\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThe author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials.\u003c\/p\u003e \u003cp\u003eClinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.\u003c\/p\u003e Preface xv \u003cp\u003e1. Introduction 1\u003c\/p\u003e \u003cp\u003e2. Fundamentals of Clinical Trials 13\u003c\/p\u003e \u003cp\u003e3. Frequentist versus Bayesian Statistics 29\u003c\/p\u003e \u003cp\u003e4. Phase I Trial Design 77\u003c\/p\u003e \u003cp\u003e5. Phase II Trial Design 115\u003c\/p\u003e \u003cp\u003e6. Phase III Trial Design 159\u003c\/p\u003e \u003cp\u003e7. Adaptive Randomization 223\u003c\/p\u003e \u003cp\u003e8. Late-Onset Toxicity 253\u003c\/p\u003e \u003cp\u003e9. Drug-Combination Trials 271\u003c\/p\u003e \u003cp\u003e10. Targeted Therapy Design 297\u003c\/p\u003e \u003cp\u003eReferences 311\u003c\/p\u003e \u003cp\u003eAuthor Index 329\u003c\/p\u003e \u003cp\u003eSubject Index 333\u003c\/p\u003e  \u003cp\u003e“In summary, this book is useful for anyone interested in design and analysis of clinical studies. The main strengths of this book are the well-balanced approach between statistical theories and statistical analysis methods of the design issues involved in clinical trials. I would suggest the usage of this book as a Master’s level course in biostatistics.”  (\u003ci\u003eJournal of Biopharmaceutical Statistics\u003c\/i\u003e, 1 May 2013)\u003c\/p\u003e \u003cp\u003e“The author should be commended; the text is well written and packed with information that belies the book’s trim size.\"  (\u003ci\u003eDrug Information Journal\u003c\/i\u003e, 30 October 2012)\u003c\/p\u003e \u003cp\u003e“The book accompanied with software developed at MD Anderson Cancer Center provides an excellent reference for everyone who works in clinical trial field.”  (\u003ci\u003eBiometrics\u003c\/i\u003e, 1 July 2012)\u003c\/p\u003e \u003cp\u003eGUOSHENG YIN, PhD, is Associate Professor in the Department of Statistics and Actuarial Science at The University of Hong Kong, and Adjunct Associate Professor in the Department of Biostatistics at The University of Texas MD Anderson Cancer Center. \u003c\/p\u003e   \u003cp\u003eA balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods\u003c\/p\u003e \u003cp\u003eThere has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics.\u003c\/p\u003e \u003cp\u003eRecognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eRisk and benefit analysis for toxicity and efficacy trade-offs\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBayesian predictive probability trial monitoring\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBayesian adaptive randomization\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eLate onset toxicity and response\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDose finding in drug combination trials\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eTargeted therapy designs\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThe author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials.\u003c\/p\u003e \u003cp\u003eClinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47988935557349,"sku":"NP9780470581711","price":141.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470581711.jpg?v=1761782117","url":"https:\/\/k12savings.com\/products\/clinical-trial-design-isbn-9780470581711","provider":"K12savings","version":"1.0","type":"link"}