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008			150903s2007 it | o |||| 0|eng d
020			_a9788847004924 _99788847004924
024	7		_a10.1007/9788847004924 _2doi
035			_avtls000364277
039		9	_a201509031026 _bVLOAD _c201405070354 _dVLOAD _y201402211209 _zstaff
040			_aMX-SnUAN _bspa _cMX-SnUAN _erda
050		4	_aR858-859.7
100	1		_aBacchieri, Antonella. _eautor _9352281
245	1	0	_aFundamentals of Clinical Research : _bBridging Medicine, Statistics and Operations / _cby Antonella Bacchieri, Giovanni Cioppa.
264		1	_aMilano : _bSpringer Milan, _c2007.
300			_axxv, 343 páginas _brecurso en línea.
336			_atexto _btxt _2rdacontent
337			_acomputadora _bc _2rdamedia
338			_arecurso en línea _bcr _2rdacarrier
347			_aarchivo de texto _bPDF _2rda
490	0		_aStatistics for Biology and Health, _x1431-8776
500			_aSpringer eBooks
505	0		_aViability of Biological Phenomena and Measurement Errors -- Distinctive Aspects of a Biomedical Study Observational and Experimental Studies -- Observational Studies -- Defining the Treatment Effect -- Probability, Inference and Decision Making -- The Choice of the Sample -- The Choice of Treatments -- Experimental Design: Fallacy of “Before-After” Comparisons in Uncontrolled Studies -- Experimental Design: the Randomized Blinded Study as an Instrument to Reduce Bias -- Experimental Designs -- Study Variants Applicable to More than One Type of Design: Equivalence Studies, Interim Analyses, Adaptive Plans and Repeated Measurements -- The Drug Development Process and the Phases of Clinical Research.
520			_aThe scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species.The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages. A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol. The book ends with a brief description of the drug development process and to the phases of clinical development. The authors
590			_aPara consulta fuera de la UANL se requiere clave de acceso remoto.
700	1		_aCioppa, Giovanni. _eautor _9352282
710	2		_aSpringerLink (Servicio en línea) _9299170
776	0	8	_iEdición impresa: _z9788847004917
856	4	0	_uhttp://remoto.dgb.uanl.mx/login?url=http://dx.doi.org/10.1007/978-88-470-0492-4 _zConectar a Springer E-Books (Para consulta externa se requiere previa autentificación en Biblioteca Digital UANL)
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