000 03634nam a22005055i 4500
001 978-3-319-22005-5
003 DE-He213
005 20161006171610.0
007 cr nn 008mamaa
008 150820s2015 gw | s |||| 0|eng d
020 _a9783319220055
_9978-3-319-22005-5
024 7 _a10.1007/978-3-319-22005-5
_2doi
050 4 _aQA276-280
072 7 _aPBT
_2bicssc
072 7 _aMAT029000
_2bisacsh
082 0 4 _a519.5
_223
100 1 _aSozu, Takashi.
_eauthor.
245 1 0 _aSample Size Determination in Clinical Trials with Multiple Endpoints
_h[electronic resource] /
_cby Takashi Sozu, Tomoyuki Sugimoto, Toshimitsu Hamasaki, Scott R. Evans.
250 _a1st ed. 2015.
264 1 _aCham :
_bSpringer International Publishing :
_bImprint: Springer,
_c2015.
300 _aVI, 95 p. 17 illus.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aSpringerBriefs in Statistics,
_x2191-544X
505 0 _a1.Introduction -- 2.Continuous Co-primary Endpoints -- 3.Binary Co-primary Endpoints -- 4.Convenient Sample Size Formula -- 5.Continuous Primary Endpoints -- 6. Further Developments -- A.Sample Size Calculation Using other Contrasts for Binary Endpoints -- B.Empirical Power for Sample Size Calculation for Binary Co-primary Endpoints -- C.Numerical Tables for Ck in the Convenient Sample Size Formula for the Three Co-primary Continuous Endpoints Cace -- D.Software Programs for Sample Size Calculation for Continuous Co-primary Endpoints -- References.
520 _aThis book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.  .
650 0 _aStatistics.
650 0 _aBiostatistics.
650 1 4 _aStatistics.
650 2 4 _aStatistical Theory and Methods.
650 2 4 _aStatistics for Life Sciences, Medicine, Health Sciences.
650 2 4 _aBiostatistics.
700 1 _aSugimoto, Tomoyuki.
_eauthor.
700 1 _aHamasaki, Toshimitsu.
_eauthor.
700 1 _aEvans, Scott R.
_eauthor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783319220048
830 0 _aSpringerBriefs in Statistics,
_x2191-544X
856 4 0 _uhttp://dx.doi.org/10.1007/978-3-319-22005-5
912 _aZDB-2-SMA
999 _c227121
_d227121