04913cam a2200529Ii 4500 77267 314544 919463985 OCoLC 20190822094036.0 m o d cr cnu---unuuu 150831s2015 nyua ob 001 0 eng d 331918539X electronic bk 9783319185392 electronic bk 3319185381 (print) 9783319185385 9783319185385 (print) 10.1007/978-3-319-18539-2 doi (OCoLC)919463985 GW5XE eng rda pn GW5XE YDXCP UPM COO R853.C55 610.724 23 FUC Fundamentals of clinical trials / Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger Fifth edition Fifth edition New York : Springer, [2015] ℗♭2015 1 online resource (xxi, 550 pages) : illustrations Includes bibliographical references and index Introduction to Clinical Trials -- Ethical Issues -- What is the Question? -- Study Population -- Basic Study Design -- The Randomization Process -- Blinding -- Sample Size -- Baseline Assessment -- Recruitment of Study Participants -- Data Collection and Quality Control -- Assessment and Reporting of Harm -- Assessment of Health Related Quality of Life -- Participant Adherence -- Survival Analysis -- Monitoring Committee Structure & Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues Available to OhioLINK libraries This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. 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 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. Clinical trials. 74862 Clinical Trials as Topic. 74863 Research Design. 74864 Electronic books. 74865 DeMets, David L., 1944- author. 74866 Friedman, Lawrence M., 1942- author. 74867 Furberg, Curt, author. 74868 Granger, Christopher B., author. 74869 Reboussin, David M., author. 74870 Ohio Library and Information Network. 74871 Printed edition: 9783319185385 http://rave.ohiolink.edu/ebooks/ebc/9783319185392 OhioLINK Connect to resource http://link.springer.com/10.1007/978-3-319-18539-2 SpringerLink Connect to resource http://proxy.ohiolink.edu:9099/login?url=http://link.springer.com/10.1007/978-3-319-18539-2 SpringerLink Connect to resource (off-campus) ddc BOOK 0 2019-08-22 0 0 610.724 FUC 2019-08-22 CL 00157957 CL 2019-08-22 00:00:00 BOOK ddc 0 0 2019-08-22 0 0 610.724 FUC 2019-08-22 CL 00157958 CL 2019-08-22 00:00:00 BOOK ddc 0 0 2019-08-22 0 0 610.724 FUC 2019-08-22 CL 00157959 CL 2019-08-22 00:00:00 BOOK ddc 0 0 2019-08-22 0 0 610.724 FUC 2019-08-22 AMF 00157960 AMF 2019-08-22 00:00:00 BOOK ddc 0 0 2019-08-22 0 0 610.724 FUC 2019-08-22 AMF 00157961 AMF 2019-08-22 00:00:00 BOOK ddc 0