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008			150827s2015 gw |||| o |||| 0|eng
010			_a 2019750767
020			_a9783319185392
024	7		_a10.1007/978-3-319-18539-2 _2doi
035			_a(DE-He213)978-3-319-18539-2
040			_aDLC _beng _epn _erda _cDLC
072		7	_aMBNS _2thema
072		7	_aMED090000 _2bisacsh
072		7	_aPBT _2bicssc
072		7	_aPBT _2thema
082	0	4	_a519.5 _223
100	1		_aFriedman, Lawrence M, _eauthor.
245	1	0	_aFundamentals of Clinical Trials / _cby Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger.
250			_a5th ed. 2015.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2015.
300			_a1 online resource (XXI, 550 pages 49 illustrations, 7 illustrations in color.)
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
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 and Function -- Statistical Methods Used in Interim Monitoring -- Issues in Data Analysis -- Closeout -- Reporting and Interpreting of Results -- Multicenter Trials -- Regulatory Issues.
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.
588			_aDescription based on publisher-supplied MARC data.
650		0	_aCancer research.
650		0	_aEpidemiology.
650		0	_aOncology.
650		0	_aPublic health.
650		0	_aStatistics.
650	1	4	_aStatistics for Life Sciences, Medicine, Health Sciences. _0https://scigraph.springernature.com/ontologies/product-market-codes/S17030
650	2	4	_aCancer Research. _0https://scigraph.springernature.com/ontologies/product-market-codes/B11001
650	2	4	_aEpidemiology. _0https://scigraph.springernature.com/ontologies/product-market-codes/H63000
650	2	4	_aOncology. _0https://scigraph.springernature.com/ontologies/product-market-codes/H33160
650	2	4	_aPublic Health. _0https://scigraph.springernature.com/ontologies/product-market-codes/H27002
700	1		_aDeMets, David L, _eauthor.
700	1		_aFurberg, Curt D, _eauthor.
700	1		_aGranger, Christopher B, _eauthor.
700	1		_aReboussin, David M, _eauthor.
776	0	8	_iPrint version: _tFundamentals of clinical trials. _z9783319185385 _w(DLC) 2015942127
776	0	8	_iPrinted edition: _z9783319185385
776	0	8	_iPrinted edition: _z9783319185408
776	0	8	_iPrinted edition: _z9783319307732
906			_a0 _bibc _corigres _du _encip _f20 _gy-gencatlg
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