Sample size calculations for comparative clinical trials with over-dispersed Poisson process data
作者： Shigeyuki Matsui
DOI: 10.1002/SIM.2011
关键词: Rate function 、 Event (probability theory) 、 Poisson process 、 Basis (linear algebra) 、 Statistics 、 Mathematics 、 Clinical trial 、 Sample size determination 、 Poisson distribution 、 Statistics and Probability 、 Epidemiology
摘要: This paper develops a new formula for sample size calculations comparative clinical trials with Poisson or over-dispersed process data. The criteria is developed on the basis of asymptotic approximations two-sample non-parametric test to compare empirical event rate function between treatment groups. can accommodate time heterogeneity, inter-patient heterogeneity in rate, and also, time-varying effects. An application trial chronic granulomatous disease provided.
sci-hub.se 参考文章(33)
N. E. Breslow, Extra‐Poisson Variation in Log‐Linear Models Applied statistics. ,vol. 33, pp. 38- 44 ,(1984) , 10.2307/2347661
P. J. Cheek, P. McCullagh, J. A. Nelder, Generalized Linear Models, 2nd Edn. Applied Statistics. ,vol. 39, pp. 385- 386 ,(1990) , 10.2307/2347392
D. F. Moore, A. Tsiatis, Robust estimation of the variance in moment methods for extra-binomial and extra-Poisson variation. Biometrics. ,vol. 47, pp. 383- 401 ,(1991) , 10.2307/2532133
Shigeyuki Matsui, Yasuo Ohashi, Analysis of recurrent events: application to a clinical trial of colony stimulating factor with the endpoint of febrile neutropenia. Statistics in Medicine. ,vol. 18, pp. 2409- 2420 ,(1999) , 10.1002/(SICI)1097-0258(19990915/30)18:17/18<2409::AID-SIM265>3.0.CO;2-8
Guanghan Liu, Kung-Yee Liang, Sample size calculations for studies with correlated observations. Biometrics. ,vol. 53, pp. 937- 947 ,(1997) , 10.2307/2533554
J. F. Lawless, Regression Methods for Poisson Process Data Journal of the American Statistical Association. ,vol. 82, pp. 808- 815 ,(1987) , 10.1080/01621459.1987.10478502
MICHAEL D. HUGHES, Power considerations for clinical trials using multivariate time-to-event data. Statistics in Medicine. ,vol. 16, pp. 865- 882 ,(1997) , 10.1002/(SICI)1097-0258(19970430)16:8<865::AID-SIM541>3.0.CO;2-D
Shigeyuki Matsui, Hideaki Miyagishi, Design of clinical trials for recurrent events with periodic monitoring. Statistics in Medicine. ,vol. 18, pp. 3005- 3020 ,(1999) , 10.1002/(SICI)1097-0258(19991130)18:22<3005::AID-SIM207>3.0.CO;2-8
Margaret Sullivan Pepe, Jianwen Cai, Some Graphical Displays and Marginal Regression Analyses for Recurrent Failure Times and Time Dependent Covariates Journal of the American Statistical Association. ,vol. 88, pp. 811- 820 ,(1993) , 10.1080/01621459.1993.10476346
Norman Breslow, Tests of Hypotheses in Overdispersed Poisson Regression and other Quasi-Likelihood Models Journal of the American Statistical Association. ,vol. 85, pp. 565- 571 ,(1990) , 10.1080/01621459.1990.10476236