000 04165nam a22004335i 4500
001 978-1-4020-0570-1
003 DE-He213
005 20161121231030.0
007 cr nn 008mamaa
008 100301s2006 ne | s |||| 0|eng d
020 _a9781402005701
_9978-1-4020-0570-1
024 7 _a10.1007/1-4020-0570-9
_2doi
050 4 _aQA276-280
072 7 _aPBT
_2bicssc
072 7 _aMBNS
_2bicssc
072 7 _aMED090000
_2bisacsh
082 0 4 _a519.5
_223
100 1 _aCleophas, Ton J.
_eauthor.
245 1 0 _aStatistics Applied to Clinical Trials
_h[electronic resource] /
_cby Ton J Cleophas, Aeilko H Zwinderman, Toine F Cleophas.
264 1 _aDordrecht :
_bSpringer Netherlands,
_c2006.
300 _aXIII, 210 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aPreface -- Foreword -- 1. Hypotheses, Data, Stratification -- 2. The analysis of efficacy data of drug trials -- 3. The analysis of safety data of drug trials -- 4. Equivalence testing -- 5. Statistical power and sample size -- 6. Interim analysis -- 7. Multiple statistical inferences -- 8. Principles of linear regression -- 9. Subgroup analysis multiple linear regression: confounding, interaction, synergism -- 10. Curvilinear regression -- 11. Meta-analysis -- 12. Crossover studies with continuous variables: power analysis -- 13. Crossover studies with binary responses -- 14. Post-hoc analysis in clinical trials, a case for logistic regression analysis -- 15. quality-of-life assessment in clinical trials -- 16. Statistics for the analysis of genetic data -- 17. Relationship among statistical distributions -- 18. Statistics is not "bloodless" algebra -- Appendix -- Index.
520 _aIn 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, etc. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly better quality than before. The past decade has focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial bodies, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. This book not only explains classical statistical analyses of clinical trials, but addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. The book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.
650 0 _aStatistics.
650 1 4 _aStatistics.
650 2 4 _aStatistics for Life Sciences, Medicine, Health Sciences.
700 1 _aZwinderman, Aeilko H.
_eauthor.
700 1 _aCleophas, Toine F.
_eauthor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9781402042294
856 4 0 _uhttp://dx.doi.org/10.1007/1-4020-0570-9
912 _aZDB-2-SMA
950 _aMathematics and Statistics (Springer-11649)
999 _c507542
_d507542