Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 4, 2010, Pages 705-719

  Lu, Qingshu ^a   Tse, Siu Keung ^b   Chow, Shein Chung ^c  

^a UNIVERSITY OF SCIENCE AND TECHNOLOGY OF CHINA   (China)

^b CITY UNIVERSITY OF HONG KONG   (Hong Kong)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Cox's proportional hazard model; Sample size determination; Time to event data; Two stage adaptive design; Weibull model

Indexed keywords

ARTICLE; CLINICAL STUDY; DATA ANALYSIS; HYPOTHESIS; MATHEMATICAL COMPUTING; MATHEMATICAL MODEL; POWER ANALYSIS; PRIORITY JOURNAL; PROPORTIONAL HAZARDS MODEL; SAMPLE SIZE; STUDY DESIGN; TIME TO EVENT DATA; TREATMENT DURATION; TWO STAGE SURVIVAL ADAPTIVE DESIGN; WEIBULL MODEL;

ALGORITHMS; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; EPIDEMIOLOGIC RESEARCH DESIGN; HUMANS; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; PROPORTIONAL HAZARDS MODELS; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY; TIME FACTORS; TREATMENT OUTCOME;

EID: 77952948451     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543401003618066     Document Type: Article

References (8)

1. Chow, S. C., Chang, M. (2006). Adaptive Design Methods in Clinical Trials. New York: Taylor and Francis.
2. Chow, S. C., Lu, Q. S., Tse, S. K. (2007). Statistical analysis for two-stage seamless design with different study endpoints. Journal of Biopharmaceutical Statistics 17:1163-1176.
3. Cox, D. R. (1972). Regression models and life tables (with discussion). Journal of Royal Statistical Society B 74:187-220.
4. Cox, D. R., Hinkley, D. V. (1974). Theoretical Statistics. London: Chapman and Hall.
5. Lu, Q. S., Tse, S. K., Chow, S. C., Chi, Y., Yang, L. Y. (2009). Sample size estimation based on event data for a two-stage survival adaptive trial with different durations. Journal of Biopharmaceutical Statistics 19:311-323.
6. Maca, J., Bhattacharya, S., Dragalin, V., Gallo, P., Krams, M. (2006). Adaptive seamless phase II/III designs-Background, operational aspects, and examples. Drug Information Journal 40:463-474.
7. Schoenfeld, D. (1981). The asymptotic properties of nonparametric tests for comparing survival distributions. Biometrika 68:316-319.
8. Serfling, R. J. (1980). Approximation Theorems of Mathematical Statistics. New York: John Wiley & Sons.