000 02446nam a22002417a 4500
001 20241105143403.0
003 OCoLC
005 20241105143949.0
008 241105b |||||||| |||| 00| 0 eng d
010 _a 20150617
020 _a978-1-4822-5050-3 (eBook - PDF)
040 _cddc
041 _aEnglish
100 _qWeichung Joe Shih
240 _aStatistical Design and Analysis of Clinical Trials.
245 _aStatistical Design and Analysis of Clinical Trials
_bPrinciples and Methods.
260 _aBoca Raton, FL 33487-2742 |
_bTaylor & Francis Group, LLC CRC |
_c 2016.
300 _a240 Pages
520 _aStatistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
600 _xBiostatistics
700 _qJoseph Aisner
942 _2ddc
_cEB
_n0
999 _c29647
_d29647