Duration of Accrual and Follow-up for Two-Stage Clinical Trials

Lifetime Data Analysis

Volumn 7, Issue 1, 2001, Pages 21-37

  Case, L Douglas ^a   Morgan, Timothy M ^a  

^a WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; Cox model; Group sequential designs; Proportional hazards model; Sample size; Survival analysis; Two stage design

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; FOLLOW UP; HUMAN; LUNG TUMOR; METHODOLOGY; PATIENT SELECTION; PROPORTIONAL HAZARDS MODEL; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SMALL CELL CARCINOMA; SURVIVAL;

ANTINEOPLASTIC AGENTS; CARCINOMA, SMALL CELL; CLINICAL TRIALS; FOLLOW-UP STUDIES; HUMANS; LUNG NEOPLASMS; PATIENT SELECTION; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SAMPLE SIZE; SURVIVAL ANALYSIS;

EID: 0035286219     PISSN: 13807870     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1009621009283     Document Type: Article

References (18)

1. L. D. Case, T. M. Morgan and C. E. Davis, "Optimal restricted two-stage designs," Controlled Clinical Trials vol. 8, pp. 146-155, 1987.
2. T. Colton and K. McPherson, "Two-stage plans compared with fixed-sample-size and Wald SPRT-plans," Journal of the American Statistical Association vol. 71, pp. 80-86, 1976.
3. D. R. Cox, "Regression models and life-tables (with discussion)," Journal of the Royal Statistical Society, Series B vol. 34, pp. 187-220, 1972.
4. C. De With, "Two-stage plans for the testing of binomial parameters," Controlled Clinical Trials vol. 4, pp. 215-226, 1983.
5. M. H. Gail, D. L. DeMets and E. V. Slud, "Simulation studies on increments of the two-sample logrank test for survival time data, with application to group sequential boundaries," In Survival Analysis, Ed. J. Crowley and R. A. Johnson, pp. 287-301, Hayward, California: IMS Monograph Series, 1982.
6. S. L. George and M. M. Desu, "Planning the size and duration of a clinical trial studying the time to some critical event," Journal of Chronic Diseases, vol. 27, pp. 15-29, 1974.
7. A. Hald, "Optimum double sampling tests of given strength. I. The normal distribution," Journal of the American Statistical Association vol. 70, pp. 451-456, 1975.
8. D. V. Jackson, P. J. Zekan, R. D. Caldwell, M. L. Slatkoff, R. W. Harding, L. D. Case, J. Hopkins, H. B. Muss, F. Richards, D. R. White, M. R. Cooper, J. J. Stuart, R. L. Capizzi and C. L. Spurr, "VP-16-214 in combination chemotherapy with chest irradiation for small-cell lung cancer: A randomized trial of the Piedmont Oncology Association." Journal of Clinical Oncology vol. 2, pp. 1343-1351, 1984.
9. K. Kim and A. A. Tsiatis, "Study duration for clinical trials with survival response and early stopping rule," Biometrics vol. 46, pp. 81-92, 1990.
10. K. K. G. Lan and D. L. DeMets, "Discrete sequential boundaries for clinical trials," Biometrika vol. 70, pp. 659-663, 1983.
11. T. M. Morgan, "Planning the duration of accrual and follow-up for clinical trials," Journal of Chronic Diseases vol. 38, pp. 1009-1018, 1985.
12. T. M. Morgan, "Nonparametric estimation of duration of accrual and total study length for clinical trials," Biometrics vol. 43, pp. 903-912, 1987.
13. D. B. Owen, "A double sample procedure," Annals of Mathematical Statistics vol. 24, pp. 449-457, 1953.
14. L. V. Rubinstein, M. H. Gail, and T. J. Santner, "Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation," Journal of Chronic Diseases vol. 34, pp. 469-479, 1981.
15. D. A. Schoenfeld, "Sample-size formula for the proportional-hazards regression model," Biometrics vol. 39, pp. 499-503, 1983.
16. R. Simon, "Optimal two-stage designs for phase II clinical trials," Controlled Clinical Trials vol. 10, pp. 1-10, 1989.
17. A. A. Tsiatis, "The asymptotic joint distribution of the efficient scores test for the proportional hazards model calculated over time," Biometrika vol. 68, pp. 311-315, 1981.
18. A. A. Tsiatis, G. L. Rosner and D. L. Tritchler, "Group sequential tests with censored survival data adjusting for covariates," Biometrika vol. 72, pp. 365-373, 1985.