Sample size calculation for clinical studies on the efficacy of a new contraceptive method

Biometrical Journal

Volumn 46, Issue 1, 2004, Pages 141-150

  Benda, Norbert ^a   Gerlinger, Christoph ^a   Van Der Meulen, Egbert A ^b   Endrikat, Jan ^a  

^a BAYER PHARMA AG   (Germany)

^b NV ORGANON   (Netherlands)

Author keywords

Confidence interval; Pearl Index; Poisson model; Sample Size

Indexed keywords

GEMS;

'CURRENT; CLINICAL STUDY; CONFIDENCE INTERVAL; DROP-OUT; EXPOSURE-TIME; MEDICINAL PRODUCTS; PEARL-INDEX; POISSON MODEL; SAMPLE SIZES; SIZE CALCULATIONS;

DROPS;

EID: 26844532076     PISSN: 03233847     EISSN: None     Source Type: Journal    
DOI: 10.1002/bimj.200210008     Document Type: Article

References (8)

1. The European Agency for the Evaluation of Medicinal Products (EMEA) (2000). Note for Guidance on Clinical Investigation of Steroid Contraceptives in Women. CPMP/EWP/519/98.
2. The European Agency for the Evaluation of Medicinal Products (EMEA) (1997). Points to Consider on Hormone Replacement Therapy. CPMP/EWP/021/97.
3. Trussel, J. (1991). Methodological pitfalls in the analysis of contraceptive failure. Statistics in Medicine 10, 201-220.
4. Sheps, M. C. (1966). Characteristics of a ratio used to estimate failure rates. Biometrics 22, 310-321.
5. Cesana, B. M., Reina, G., Marubini, E. (2001). Sample size for testing a proportion in clinical trials: a "two-step" procedure combining power and confidence interval expected width. The American Statistician 55, 288-292.
6. Pearl, R. (1933). Factors in human fertility and their statistical evaluation. Lancet 2, 607-611.
7. Johnson, N. L. and Kotz S. (1970). Continuous Univariate Distribution 1. Houghton Mifflin, Boston.
8. Johnson, N. L., Kotz, S., and Balakrishnan, N. (1995). Continuous Univariate Distribution 1. 2nd Ed. Wiley, New York.