Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution

Journal of Biopharmaceutical Statistics

Volumn 22, Issue 4, 2012, Pages 773-784

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

^a SINGAPORE CLINICAL RESEARCH INSTITUTE   (Singapore)

^b CITY UNIVERSITY OF HONG KONG   (Hong Kong)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Loss to follow up; Nonuniform entry; Sample size determination; Time to event data; Two stage adaptive design; Weibull model

Indexed keywords

ARTICLE; CALCULATION; DRUG INDUSTRY; FOLLOW UP; HOSPITAL ADMISSION; HUMAN; HYPOTHESIS; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICS; STUDY DESIGN; TIME; WEIBULL MODEL;

ALGORITHMS; CONTROLLED CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; EPIDEMIOLOGIC RESEARCH DESIGN; HUMANS; MODELS, STATISTICAL; STATISTICAL DISTRIBUTIONS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84863473563     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2012.678528     Document Type: Article

References (13)

1. Al-Saleh, M. F., Samuh, M. H. (2008). On multistage ranked set sampling for distribution and median estimation. Computational Statistics & Data Analysis 52:2066-2078. (Pubitemid 350051446)
2. Chow, S. C., Chang, M. (2006). Adaptive Design Methods in Clinical Trials. New York: Taylor and Francis.
3. 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.
4. Chow, S. C., Shao, J., Wang, H. (2003). Sample Size Calculations in Clinical Research. New York: Dekker.
5. Efron, B., Hinkley, D. V. (1978). Assessing the accuracy of the maximum likelihood estimator: observed versus expected Fisher information. Biometrika 65:457-482.
6. Enanoria, W. T., et al. (2007). Early prediction of median survival among a large AIDS surveillance cohort. BMC Public Health 7:127.
7. Gallo, P., Chuang-Stein, C., Dragalin, V., Gaydos, B., Krams, M., Pinheiro, J. (2006). Adaptive design in clinical drug development - An executive summary of the PhRMA Working Group (with discussions). Journal of Biopharmaceutical Statistics 16:275-283.
8. Kalbfleisch, J. D., Prentice, R. L. (2002). The Statistical Analysis of Failure Time Data. 2nd ed. Hoboken, NJ: Weily.
9. Lachin, J. M., Foulkes, M. A. (1986). Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics 42:507-519.
10. Lehmann, E. L., Casella, G. (1998). Theory of Point Estimation. New York: Springer.
11. 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 40:463-473. (Pubitemid 44721124)
12. Pong, A., Chow, C. S. (2011). Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. New York: Taylor & Francis Group.
13. Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioequivalence. Journal of Phamacokinetics and Biopharmaceutics 15:657-680.