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020 _a9781584888048
040 _aCSL
_beng
_cCSL
041 _aeng
084 _aB288 Q2 TB
_qCSL
100 _a Rothmann, Mark D.
_eauthor.
_9815742
245 0 _aDesign and Analysis of Non-Inferiority Trials
_c/ by Mark D. Rothmann, Brian L. Wiens and Ivan S.F. Chan
260 _aBoca :
_bRaton C R C,
_c2012.
300 _axvi, 438p.
490 _aChapman & Hall/CRC Biostatistics
500 _aIncludes bibliographical references and Index 433-438p.
520 _aThe increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority trial. Each chapter begins with a non-technical introduction, making the text easily understood by those without prior knowledge of this type of trial.A variety of issues of non-inferiority trials, including multiple comparisons, missing data, analysis population, the use of safety margins, the internal consistency of non-inferiority inference, the use of surrogate endpoints, trial monitoring, and equivalence trials Specific issues and analysis methods when the data are binary, continuous, and time-to-event The history of non-inferiority trials and the design and conduct considerations for a non-inferiority trial The strength of evidence of an efficacy finding and how to evaluate the effect size of an active control therapy.A comprehensive discussion on the purpose and issues involved with non-inferiority trials, Design and Analysis of Non-inferiority Trials will assist current and future scientists and statisticians on the optimal design of non-inferiority trials and in assessing the quality of non-inferiority comparisons done in practice.
650 _aDesign and analysis of non-inferiority trials.
_9815743
650 _aMathematics.
650 _aStatistics.
700 _aWiens, Brian L.
_eco-author.
_9815744
700 _aChan, Ivan S. F.
_eco-author.
_9815745
942 _hB288, Q2 TB
_cTEXL
_2CC
_n0
999 _c6341
_d6341