On the use of the ratio or the odds ratio of cure rates in therapeutic equivalence clinical trials with binary endpoints
作者： Dongsheng Tu
DOI: 10.1080/10543409808835238
关键词: Sample size determination 、 Therapeutic equivalence 、 Statistics 、 Equivalence (measure theory) 、 Mathematics 、 Odds ratio 、 Clinical trial 、 Bioequivalence 、 Clinical endpoint
摘要: We discuss in this paper some issues related to the use of ratio or odds cure rates therapeutic equivalence clinical trials with binary endpoints. Some two one-sided tests procedures are proposed and their fixed sample performances evaluated by Monte Carlo simulations. Sample size formulas derived for most these procedures. The con-sequences applying acceptance limits pharmacokinetic responses bioequivalence studies endpoints also described.
sci-hub.se 参考文章(27)
Simon R, Makuch R, Sample size requirements for evaluating a conservative therapy. Cancer treatment reports. ,vol. 62, pp. 1037- ,(1978)
David E. Hapeman, Categorical Data Analysis Technometrics. ,vol. 33, pp. 241- 241 ,(1991) , 10.1080/00401706.1991.10484817
Thomas R. Ten Have, Vernon M. Chinchilli, The analysis of bioequivalence with respect to TMAX under a 2 x 2 crossover design. Journal of Biopharmaceutical Statistics. ,vol. 5, pp. 185- 199 ,(1995) , 10.1080/10543409508835107
Jen-Pei Liu, Shein-Chung Chow, On Assessment of Bioequivalence for Drugs with Negligible Plasma Levels Biometrical Journal. ,vol. 35, pp. 109- 123 ,(1993) , 10.1002/BIMJ.4710350111
Tu Dongsheng, Two one-sided tests procedures in establishing therapeutic equivalence with binary clinical endpoints: fixed sample performances and sample size derformination Journal of Statistical Computation and Simulation. ,vol. 59, pp. 271- 290 ,(1997) , 10.1080/00949659708811860
Donald J. Schuirmann, A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability Journal of Pharmacokinetics and Biopharmaceutics. ,vol. 15, pp. 657- 680 ,(1987) , 10.1007/BF01068419
Richard B. McHugh, Chap T. Le, Confidence estimation and the size of a clinical trial Controlled Clinical Trials. ,vol. 5, pp. 157- 163 ,(1984) , 10.1016/0197-2456(84)90121-1
F. J. ANSCOMBE, On estimating binomial response relations Biometrika. ,vol. 43, pp. 461- 464 ,(1956) , 10.1093/BIOMET/43.3-4.461
Jen-pei Liu, Shein-Chung Chow, Sample size determination for the two one-sided tests procedure in bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics. ,vol. 20, pp. 101- 104 ,(1992) , 10.1007/BF01143188
David R. Bristol, Probabilities and sample sizes for the two one-sided tests procedure Communications in Statistics-theory and Methods. ,vol. 22, pp. 1953- 1961 ,(1993) , 10.1080/03610929308831127