More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis issues associated with the assessment of HRQoL. At the end of a study, clinicians and statisticians often face challenging and sometimes insurmountable analytic problems. Design and Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of solutions. Written from the author's extensive experience in the field, it focuses on the very specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of missing data. The author uses three real clinical trials throughout her discussions to illustrate practical implementation of the strategies and analytic methods presented. As Quality of Life becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians, statisticians, and designers of these studies to understand and meet the challenges this kind of data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear, concise presentation combine to provide readers with the tools and skills they need to successfully design, conduct, analyze, and report their own studies.
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"This book not only provides a comprehensive review of the growing literatures and research activities, but also sheds light on new strategic and research directions. Throughout the book chapters, many real examples or simulation studies are used to illustrate the concepts, which make the contents relevant for the reader sand easier to understand. ... In general, this book provides an excellent source of references for anyone, including statisticians and non-statisticians, who are interested in global drug development and registration."
―William W.B. Wang, Merck Research Laboratories, Merck & Co., Inc., Beijing, China
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