Accounting for variability in sample size estimation with applications to nonadherence and estimation of variance and effect size

Biometrics

Volumn 63, Issue 2, 2007, Pages 465-474

  Fay, Michael P ^a   Halloran, M Elizabeth ^b,c   Follmann, Dean A ^a  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Binomial; Compliance; Normal; Poisson; Power; Sample size

Indexed keywords

PARAMETER ESTIMATION;

BINOMIAL; COMPLIANCE; EFFECT SIZE; NORMAL; POISSON; POWER; POWER FUNCTIONS; SAMPLE SIZES; SIZE CALCULATIONS; SOURCES OF VARIABILITY;

STOCHASTIC SYSTEMS;

MALARIA VACCINE;

CALIBRATION; ESTIMATION METHOD; MALARIA; STOCHASTICITY; VACCINE;

ANALYSIS OF VARIANCE; ARTICLE; CALCULATION; CALIBRATION; EFFECT SIZE; MALARIA; PATIENT COMPLIANCE; SAMPLE SIZE; SAMPLING; STANDARDIZATION; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICAL PARAMETERS; VARIANCE;

EID: 34547662961     PISSN: 0006341X     EISSN: 15410420     Source Type: Journal    
DOI: 10.1111/j.1541-0420.2006.00703.x     Document Type: Article

References (19)

1. Berry, D. A. (2004). Bayesian statistics and the efficiency and ethics of clinical trials. Statistical Science 19, 175 187.
2. Box, G. E. P. and Tiao, G. C. (1973). Bayesian Inference in Statistical Analysis. London : Addison-Wesley.
3. Brittain, E. and Lin, D. (2005). A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials. Statistics in Medicine 24, 1 10.
4. Cohen, J. (1977). Statistical Power Analysis for the Behavioral Sciences, revised edition. New York : Academic Press.
5. Efron, B. and Tibshirani, R. J. (1993). An Introduction to the Bootstrap. New York : Chapman and Hall.
6. Fay, M. P. and Feuer, E. J. (1997). Confidence intervals for directly standardized rates: A method based on the gamma distribution. Statistics in Medicine 16, 791 801.
7. Fay, M. P., Halloran, M. E., Follmann, D. A., Diemert, D., Dicko, A., Thera, M., Sagara, I., Klion, A., Doumbo, O., and Saul, A. (2005). The design of a Phase 2 malaria vaccine trial based on a cohort study. Poster presented at the Fourth Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference, Yaoundé, Cameroon.
8. Fleiss, J. L. (1981). Statistical Methods for Rates and Proportions, 2nd edition. New York : Wiley.
9. Ghosh, B. K. and Sen, P. K. (eds 1991). Handbook of Sequential Analysis. New York : Marcel Dekker.
10. Halloran, M. E., Longini, I. M., and Struchiner, C. J. (1996). Estimability and interpretation of vaccine efficacy using frailty mixing models. American Journal of Epidemiology 144, 83 97.
11. Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. New York : Chapman and Hall/CRC.
12. Lachin, J. M. (2000). Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials 21, 167 189 (correction 21, 526).
13. Lakatos, E. (2005). Sample size determination for clinical trials. In Encyclopedia of Biostatistics, 2nd edition, Volume 7, P. Armitage and T. Colton (eds). New York : Wiley.
14. Lawless, J. F. (1987). Negative binomial and mixed Poisson regression. Canadian Journal of Statistics 15, 209 225.
15. Lehmann, E. L. (1986). Testing Statistical Hypotheses. Pacific Grove, California : Wadsworth and Brooks/Cole.
16. Seidenfeld, T. (1992). R. A. Fisher's fiducial argument and Bayes' theorem. Statistical Science 7, 358 368.
17. Senn, S. (1997). Statistical Issues in Drug Development. New York : Wiley.
18. Smith, P. G., Rodrigues, L. C., and Fine, P. E. (1984). Assessment of the protective efficacy of vaccines against common diseases using case-control and cohort studies. International Journal of Epidemiology 13, 87 93.
19. Wittes, J. (2002). Sample size calculations for randomized controlled trials. Epidemiologic Reviews 24, 39 52.