Modifying the design of ongoing trials without unblinding

Statistics in Medicine

Volumn 17, Issue 1, 1998, Pages 89-100

  Gould, A Lawrence ^a   Shih, W Joseph ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALGORITHM; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; HUMAN; REVIEW; SAMPLE; SINGLE BLIND PROCEDURE; STATISTICS;

CLINICAL TRIALS; COST-BENEFIT ANALYSIS; DOUBLE-BLIND METHOD; HUMANS; LOGISTIC MODELS; ODDS RATIO; PILOT PROJECTS; RESEARCH DESIGN; SAMPLE SIZE; SINGLE-BLIND METHOD;

EID: 0032518741     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19980115)17:1<89::AID-SIM730>3.0.CO;2-D     Document Type: Review

References (18)

1. Gould, A. L. 'Planning and revising the sample size for a trial', Statistics in Medicine, 14, 1039-1051 (1995).
2. Gould, A. L. 'Interim analyses for monitoring clinical trials that do no materially affect the type I error rate', Statistics in Medicine, 11, 55-66 (1992).
3. Gould, A. L. and Shih, W. J. 'Sample size re-estimation without unblinding for normally distributed outcomes with unknown variances', Communications in Statistics, Part A - Theory and Methods, 21, 2833-2853 (1992).
4. Proschan, M. A., Follmann, D. A. and Waclawiw, M. A. 'Effects of assumption violations on type I error rate in group sequential monitoring', Biometrics, 48, 1131-1143 (1992).
5. Geller, N. L. 'Discussion of interim analysis: The alpha spending approach', Statistics in Medicine, 13, 1353-1356 (1994).
6. Lan, K. K. G. and Demets, D. L. 'Discrete sequential boundaries for clinical trials', Biometrika, 70, 659-663 (1983).
7. Lan, K. K. G. and Demets, D. L. 'Changing frequency of interim analysis in sequential monitoring', Biometrics, 45, 1017-1020 (1989).
8. Li, Z. and Geller, N. L. 'On the choice of times for data analysis in group sequential clinical trials', Biometrics, 47, 745-750 (1991).
9. Lan, K. K. G., Rosenberger, W. F. and Lachin, J. M. 'Use of spending functions for occasional or continuous monitoring of data in clinical trials', Statistics in Medicine, 12, 2219-2231 (1993).
10. Jennison, C. 'Efficient group sequential tests with unpredictable group sizes', Biometrika, 74, 155-165 (1987).
11. Wittes, J. and Brittain, E. 'The role of internal pilot studies in increasing the efficiency of clinical trials (with comments)', Statistics in Medicine, 9, 65-72 (1990).
12. Press, W. H., Flannery, B. P., Teukolsky, S. A. and Vetterling, W. T. Numerical Recipes in Pascal, Cambridge University Press, Cambridge, 1989.
13. 0 and incorporating costs', Biometrika, 69, 75-80 (1982).
14. Demets, D. L. and Lan, K. K. G. 'Interim analysis: The alpha spending function approach', Statistics in Medicine, 13, 1341-1352 (1994).
15. Gould, A. L. 'Issues in blinded sample size re-estimation', Communications in Statistics: Simulation and Computation, 26, 1229-1239 (1997).
16. CPMP Working Party on Efficacy of Medicinal Products. 'Biostatistical methodology in clinical trials in applications for marketing authorizations for medicinal products', Statistics in Medicine, 14, 1659-1682 (1995).
17. Dempster, A. P., Laird, N. M. and Rubin, D. B. 'Maximum likelihood from incomplete data via the EM algorithm (with discussion)', Journal of the Royal Statistical Society, Series B, 39, 1-38 (1977).
18. Fowlkes, E. B. 'Some methods for studying the mixture of two normal (lognormal) distributions', Journal of the American Statistical Association, 74, 561-575 (1979).