TY - BOOK ID - 8657086 TI - Fundamentals of Clinical Trials AU - Friedman, Lawrence M. AU - Furberg, Curt D. AU - DeMets, David L. PY - 2010 SN - 1441915850 9786613569158 1441915869 1280391235 9781441915856 PB - New York, NY : Springer New York : Imprint: Springer, DB - UniCat KW - Clinical trials as topic. KW - Clinical trials. KW - Research design. KW - Clinical trials KW - Epidemiologic Study Characteristics as Topic KW - Methods KW - Evaluation Studies as Topic KW - Research KW - Epidemiologic Methods KW - Health Care Evaluation Mechanisms KW - Science KW - Investigative Techniques KW - Research Design KW - Clinical Trials as Topic KW - Public Health KW - Natural Science Disciplines KW - Quality of Health Care KW - Analytical, Diagnostic and Therapeutic Techniques and Equipment KW - Health Care Quality, Access, and Evaluation KW - Disciplines and Occupations KW - Environment and Public Health KW - Health Care KW - Medicine KW - Mathematics KW - Physical Sciences & Mathematics KW - Health & Biological Sciences KW - Mathematical Statistics KW - Medical Research KW - Controlled clinical trials KW - Patient trials of new treatments KW - Randomized clinical trials KW - Trials, Clinical KW - Statistics. KW - Cancer research. KW - Public health. KW - Oncology. KW - Epidemiology. KW - Statistics for Life Sciences, Medicine, Health Sciences. KW - Public Health. KW - Cancer Research. KW - Clinical medicine KW - Human experimentation in medicine KW - Oncology . KW - Tumors KW - Diseases KW - Public health KW - Statistical analysis KW - Statistical data KW - Statistical methods KW - Statistical science KW - Econometrics KW - Statistics . KW - Cancer research KW - Community health KW - Health services KW - Hygiene, Public KW - Hygiene, Social KW - Public health services KW - Public hygiene KW - Social hygiene KW - Health KW - Human services KW - Biosecurity KW - Health literacy KW - Medicine, Preventive KW - National health services KW - Sanitation KW - Clinical Trials UR - https://www.unicat.be/uniCat?func=search&query=sysid:8657086 AB - This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology. ER -