Some observations on the makuch/simon approach to sample size determination in clinical trials with historical controls

Communications in Statistics Part B: Simulation and Computation

Volumn 30, Issue 3, 2001, Pages 611-621

  Kepner, James ^a   Wackerly, Dennis ^a  

^a University of Florida ^*  (United States)

Author keywords

Monte carlo; Simulations

Indexed keywords

EID: 31244435391     PISSN: 03610918     EISSN: None     Source Type: Journal    
DOI: 10.1081/SAC-100105082     Document Type: Article

References (4)

1. Makuch, R. W.; Simon, R. M. Sample Size Considerations for NonRandomized Comparative Studies. Journal of Chronic Disease, 1980; 33: 175-181.
2. Tarone, R. E. The Use of Historical Control Information in Testing for a Trend in Proportions. Biometrics, 1982; 38: 215-220.
3. Thall, P. F.; Simon, R. M. Incorporating Historical Control Data in Planning Phase II Clinical Trials. Statistics in Medicine, 1990; 9: 215-228.
4. Chang, M. N.; Shuster, J. J.; Kepner, J. L. Group Sequential Designs for Phase II Trials with Historical Controls. Controlled Clinical Trials, 1999; 20: 353-364.