http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
One of the most challenging issues for clinical trial investigators, sponsors, and regulatory officials is the interpretation of experimental results that are composed of the results of multiple statistical analyses. These analyses may include the effect of therapy on multiple endpoints, the assessment of a subgroup analysis, and the evaluation of a dose-response relationship in complex mixtures. Multiple Analyses in Clinical Trials: Fundamentals for Clinical Investigators is an essentially nonmathematical discussion of the problems posed by the execution of multiple analyses in clinical trials. It concentrates on the rationale for the analyses, the difficulties posed by their interpretation, easily understood solutions, and useful problem sets. This text will help clinical investigators understand multiple analysis procedures and the key issues when designing their own work or reviewing the research of others. This book is written for advanced medical students, clinical investigators at all levels, research groups within the pharmaceutical industry, regulators at the local, state, and federal level, and biostatisticians. Only a basic background in health care and introductory statistics is required. Dr. Lemuel A. Moyé, M.D., Ph.D. is a physician and Professor of Biometry at the University of Texas School of Public Health. He has been Co-Principal Investigator of two multinational clinical trials examining the role of innovative therapy in post myocardial infarction survival (SAVE) and the use of cholesterol reducing agents in post myocardial infarction survival in patients with normal cholesterol levels (CARE). He has authored over one hundred articles in journals such as the Journal of the American Medical Association, the New England Journal of Medicine, Statistics in Medicine, and Controlled Clinical Trials. From the reviews: From the reviews: "A quick scan of the book indicates that it is not a typical statistics book…You can jump in almost anywhere and just start reading…I like the book’s organization. There is a chapter on clinical trials. Then there are several chapters that explain the situations that arise from the occurrence of multiple analyses. Particular emphasis is given to multiple endpoints, situations where one continues a study to follow up on unanticipated results, and to subgroup analyses, interventions that impact only a fraction of the subjects in a study. The author is equally adept at describing clinical trials for the statistician as at explaining statistics to the clinical investigator. I enjoyed leafing through this book and would certainly enjoy have the opportunity to sit down and read it." Technometrics, August 2004 "Moyé’s background as a statistician and MD makes him especially qualified to write this book…The clinical trial examples are a major strength of the book…His medical background and extensive clinical trials experience shine through." Statistics in Medicine, 2004, 23:3551-3559 "The many examples from well known clinical trials are clearly one of the strengths of this book. It is also fascinating to share the author's experience with the FDA where he attended many meetings of Advisory Committees."Biometrics, December 2005 "According to the preface, this book is written for clinical investigators and research groups within the pharmaceutical industry, medical students and regulators. … I admire the eloquency of the author. … The author does a remarkable job … . Without any doubt, the book is a valuable source of ideas for the intended audience. For statisticians it is an interesting source of experimental setups, that are actually used in practice and that consequently are worth while to be studied." (dr H. W. M. Hendriks, Kwantitatieve Methoden, Issue 72B41, 2005) "The book is entertaining and informative, sufficiently informal to recruit and retain the intended non-statistical readership, but sufficiently formal to detail methods. The author effectively sets up each issue with examples and conceptual discussion, grounding all in realistic examples." (T. A. Louis, Short Book Reviews, Vol. 24 (2), 2004) "Here in this book is a special situation for clinical trials in which the investigator must do statistical analyses for a number of different response measurements. … The author felt that the clinical investigators needed a book that they could understand. This book is his effort to reach that audience. … I like the book’s organization. … I enjoyed leafing through this book and would certainly enjoy having the opportunity to sit down and read it." (Eric R. Ziegel, Technometrics, Vol. 46 (3), August, 2004) "This book is written primarily for clinical researchers who are interested in designing and analysing clinical trials. It concentrates on elucidating problems arising from multiple analyses in clinical trials … . In general, the book is well written and easy to follow. … Although this book is written for clinical investigators, I find it a useful reference book for statisticians in the pharmaceutical industry … . Furthermore, senior statisticians may find the non-technical discussions and practical examples useful." (Shuying Yang, Pharmaceutical Statistics, Issue 3, 2004) "Without any doubt, the book is a valuable source of ideas for the intendend audience. For statisticians, it is an interesting source of experimental setups, that are actually used in practice and that consequently are worthwhile to be studied." (Dr. H.W.M. Hendriks, Kwantitatieve Methoden).
Prologue -- Fundamentals of Clinical Trial Design -- Multiple Analyses and the Random Experiment -- The Lure and Complexity of Multiple Analyses -- Multiple Analyses and Multiple Endpoints -- to Multiple Dependent Analyses I -- Multiple Dependent Analyses II -- to Composite Endpoints -- Multiple Analyses and Composite Endpoints -- to Subgroup Analyses -- Subgroups II: Effect Domination and Controversy -- Subgroups III: Confirmatory Analyses -- Multiple Analyses and Multiple Treatment Arms -- Combining Multiple Analyses -- Conclusions: The Two-Front War.
Statistics for Life Sciences, Medicine, Health Sciences