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003			ES-MaUEC
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007			cr nn nnnaamaa
008			200310s2020 gw | o |||| 0|eng d
020			_a9783030354886
024	7		_a10.1007/978-3-030-35488-6 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aR853.C55 _b2020 EB
245	0	0	_aClinical Trials _cedited by Timothy M. Pawlik, Julie A. Sosa.
250			_aSecond edition 2020
264		1	_aCham _bSpringer International Publishing _c2020
300			_a1 recurso en línea (VI, 258 páginas) _b26 ilustraciones, 16 ilustraciones a color
336			_2rdacontent _aTexto _btxt
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_aArchivo de texto _bPDF
490	0		_aSuccess in Academic Surgery _x2194-7481
490	0		_aMedicine (Springer-11650)
505	0		_aHistory of Clinical Trials -- Ethics (COI, informed consent) -- Generating a Testable Hypothesis and Underlying Principles of Clinical Trials -- Trial Design: Overview of Study Designs (phase I, II, III, IV, factorial design) -- Defining the Study Cohort: Inclusion and Exclusion criteria (establishing eligibility and exclusion criteria, how should one define a cohort, balance between being inclusive versus selective / efficacy versus effectiveness trials) -- Building your Clinical Trial Research Team (how to assemble the team: database manager, research nurse) -- Clinical Trials: Ensuring Quality and Standardization (GCP, reporting of AE's, establishing SOPs, CRF's) -- Device versus Drug Clinical Trials: Similarities and Important Differences -- Statistics - Setting the Stage (Sample Size, Power, Randomization, Type II error, Treatment allocation/stratification) -- Statistics - Handling the Data (Intention to Treat analyses, Subgroups analyses, expressing the data (relative risk), handling missing data) -- Data Safety Monitoring Board: Interim Analyses, Stopping Rules -- Planning for Data Monitoring and Audit -- Clinical Trials: The Budget -- Regulatory Issues (compliance issues, IRB, FDA) -- Publishing your Clinical Trial (authorship, manuscript preparation, journal selection) -- Pragmatic clinical trials -- Cooperative trials -- International trials -- Inclusion of Patient Reported Outcomes -- Participation in clinical trials/as a clinical trialist for the community surgeon. .
520	3		_aThis extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
988			_aSpringer_Medicine_2020
650		7	_2embne _aEnsayos clínicos _9144524
700	1		_aPawlik, Timothy M. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt _0http://id.loc.gov/authorities/names/nb2014002176 _1http://viaf.org/viaf/315233456
700	1		_aSosa, Julie A. _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
710	2		_aSpringerLink (Online service) _0http://id.loc.gov/authorities/names/no2005046756 _1http://viaf.org/viaf/148105729
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783030354879
776	0	8	_iPrinted edition: _z9783030354893
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-35488-6 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b05/2020 _dz _ea _zSI