000			04913cam a2200529Ii 4500
999			_c77267 _d314544
001			919463985
003			OCoLC
005			20190822094036.0
006			m o d
007			cr cnu---unuuu
008			150831s2015 nyua ob 001 0 eng d
020			_a331918539X _qelectronic bk
020			_a9783319185392 _qelectronic bk
020			_z3319185381 (print)
020			_z9783319185385
020			_z9783319185385 (print)
024	7		_a10.1007/978-3-319-18539-2 _2doi
035			_a(OCoLC)919463985
040			_aGW5XE _beng _erda _epn _cGW5XE _dYDXCP _dUPM _dCOO
050		4	_aR853.C55
082	0	4	_a610.724 _223 _bFUC
245	0	0	_aFundamentals of clinical trials / _cLawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
250			_aFifth edition
250			_aFifth edition
264		1	_aNew York : _bSpringer, _c[2015]
264		4	_c℗♭2015
300			_a1 online resource (xxi, 550 pages) : _billustrations
504			_aIncludes bibliographical references and index
505	0		_aIntroduction 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
506			_aAvailable to OhioLINK libraries
520			_aThis 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.
650		0	_aClinical trials. _974862
650	1	2	_aClinical Trials as Topic. _974863
650	1	2	_aResearch Design. _974864
655		4	_aElectronic books. _974865
700	1		_aDeMets, David L., _d1944- _eauthor. _974866
700	1		_aFriedman, Lawrence M., _d1942- _eauthor. _974867
700	1		_aFurberg, Curt, _eauthor. _974868
700	1		_aGranger, Christopher B., _eauthor. _974869
700	1		_aReboussin, David M., _eauthor. _974870
710	2		_aOhio Library and Information Network. _974871
776	0	8	_iPrinted edition: _z9783319185385
856	4	0	_uhttp://rave.ohiolink.edu/ebooks/ebc/9783319185392 _3OhioLINK _zConnect to resource
856	4	0	_uhttp://link.springer.com/10.1007/978-3-319-18539-2 _3SpringerLink _zConnect to resource
856	4	0	_uhttp://proxy.ohiolink.edu:9099/login?url=http://link.springer.com/10.1007/978-3-319-18539-2 _3SpringerLink _zConnect to resource (off-campus)
942			_2ddc _cBOOK