Unbiased estimation of selected treatment means in two-stage trials

Biometrical Journal

Volumn 50, Issue 4, 2008, Pages 515-527

  Bowden, Jack ^a   Glimm, Ekkehard ^b  

^a MRC BIOSTATISTICS UNIT   (United Kingdom)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Adaptive trial; Point estimation; Selection bias; UMVCUE

Indexed keywords

ADAPTIVE TRIAL; CLINICAL TRIAL; CONDITION; LARGE GROUPS; POINT ESTIMATION; SELECTION BIAS; SELECTION MECHANISM; TREATMENT EFFECTS; UMVCUE; UNBIASED ESTIMATION;

MEDICAL APPLICATIONS;

EID: 54349104178     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200810442     Document Type: Article

References (15)

1. Bauer, P. and Kieser, M. (1999). Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 18, 1833-1848.
2. Cohen, A. and Sackrowitz, H. (1989). Two stage conditionally unbiased estimators of the selected mean. Statistics and Probability Letters 8, 273-278.
3. Marcus, R., Peritz, E., and Gabriel, K. (1976). On closed testing procedures with special reference to ordered analysis of variance. Biometrika 63, 655-660.
4. Posch, M., Bauer, P., and Brannath, W. (2003). Issues in designing flexible trials. Statistics in Medicine 22, 953-959.
5. Posch, M., Koenig, F., Branson, M., Brannath, W., Dunger-Baldauf, C., and Bauer, P. (2005). Testing and estimation in flexible group sequential designs with adaptive treatment selection. Statistics in Medicine 24, 3697-3714.
6. Putter, J. and Rubenstein, D. (1968). Technical report tr165: On estimating the mean of a selected population. University of Wisconsin statistics department, Wisconsin.
7. Sampson, A. and Sill, M. (2005). Drop-the-losers design: Normal case. Biometrical Journal 47, 257-268.
8. Sill, M. and Sampson, A. (2007). Extension of a two-stage conditionally unbiased estimator of the selected population to the bivariate normal case. Communications in Statistics-Theory and Methods 36, 801-813.
9. Schmidli, H., Bretz, F., Racine, A., and Maurer, W. (2006). Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: Applications and practical considerations. Biometrical Journal 48, 635-643.
10. Shen, L. (2001). An improved method of evaluating drug effect in a multiple dose clinical trial. Statistics in Medicine 20, 1913-1929.
11. Stallard, N. and Todd, S. (2003). Sequential designs for phase III clinical trials incorporating treatment selection. Statistics in Medicine 22, 689-703.
12. Stallard, N. and Todd, S. (2005). Point estimates and confidence intervals for sequential trials involving selection. Journal of Planning and Statistical Inference 135, 402-419.
13. Stallard, N., Todd, S., and Whitehead, J. (2008). Estimation following selection of the largest of two normal means. Journal of Planning and Statistical Inference 138, 1629-1638.
14. Thall, P., Simon, R., and Ellenberg, S. (1988). Two-stage selection and testing designs for comparitive clinical trials. Biometrika 75, 303-310.
15. Todd, S., Whitehead, J., and Facey, K. (1996). Point and interval estimation following a sequential clinical trial. Biometrika 83, 453-461.