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020 _a9781032009100
082 _a610.724
_bKIM
245 _aHandbook of statistical methods for randomized controlled trials
260 _bRoutledge
_aNew York
_c2021
300 _axxxiii, 620 p.
365 _aGBP
_b65.99
490 _aChapman & Hall/CRC Handbooks of Modern Statistical Methods
500 _aTable of contents: Part I. Introduction to Randomized, Controlled Trials 1. Introduction KyungMann Kim Part II. Analytic Methods for Randomized, Controlled Trials 2. Dichotomous and ordinal: chi-square and Fisher's exact tests and binary regression models Garrett Fitzmaurice, Stuart Lipsitz 3. Continuous: t-test, Wilcoxon-test, and linear or non-linear regression models Fang-Shu Ou 4. Time to event subject to censoring: logrank test, Kaplan-Meier estimation and Cox proportional hazards regression models Daniel Scharfstein, Yuxin Zhu, Anastasios Tsiatis 5. Count: Poisson and negative binomial regression models Jianguo "Tony" Sun, Xin He 6. Longitudinal: Linear and generalized linear mixed models, GEE Myunghee Cho Paik, Soeun Kim 7. Recurrent events Richard Cook, Yujie Zhong 8. Cross-over design Stephen Senn 9. Factorial design Bibhas Chakraborty, Palash Ghosh 10. Cluster randomized design Martin Bland, Mona Kanaan 11. Randomization, stratification, and outcome-adaptive allocation Oleksandr Sverdlov, Yevgen Ryeznik 12. Sample size estimation and power analysis: Dichotomous, ordinal, continuous and count Keaven Anderson, Oliver Bautista 13. Sample size estimation and power analysis: Time-to-event data subject to censoring Keaven Anderson, Oliver Bautista 14. Sample size estimation and power analysis: Longitudinal data Sin-Ho Jung 15. Group sequential methods, triangular methods and stochastic curtailments Michael Proschan 16. Sample size re-estimation Tim Friede, Tobias Mütze 17. Adaptive designs Gernot Wassmer, Franz Koenig, Martin Posch 18. Multiple testing Jason Hsu, Yi Liu, Szu-Yu Tang 19. Subgroup analysis Rui Wang 20. Competing risks Haesook Kim 21. Joint models for longitudinal markers and clinical outcomes Helene Jacqmin-Gadda, Cécile Proust-Lima, Loïc Ferrer 22. Sequential multiple assignment randomization trial (SMART) for dynamic treatment allocation Michael Kosorok, Emily Butler 23. Safety data analysis Amy Xia, Brenda Crowe, Jesse Berlin 24. Non-inferiority trials Brian Wiens 25. Incorporating historical data into RCTs Heinz Schmidli, Sandro Gsteiger, Beat Neuenschwander 26. Validation of surrogate outcomes Geert Molenberghs [https://www.routledge.com/Handbook-of-Statistical-Methods-for-Randomized-Controlled-Trials/Kim-Bretz-Cheung-Hampson/p/book/9781032009100]
520 _aStatistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes. (https://www.routledge.com/Handbook-of-Statistical-Methods-for-Randomized-Controlled-Trials/Kim-Bretz-Cheung-Hampson/p/book/9781032009100)
650 _aMedicine--Statistical method
_924717
700 _aKim, Kyung Mann [Editor]
_924681
700 _aBretz, Frank [Editor]
_924682
700 _aCheung, Ying Kuen K [Editor]
_924683
700 _aHampson, Lisa V [Editor]
_924684
942 _cBK
_2ddc
999 _c10090
_d10090