Browse > Article
http://dx.doi.org/10.5351/KJAS.2011.24.4.633

Statistical Consideration of Vaccine Clinical Trials  

Nam, Ju-Sun (Department of Statistics, Ewha Womens University, Biopharmaceutical Policy Division, KFDA)
Kang, Seung-Ho (Department of Applied Statistics, Yonsei University)
Publication Information
The Korean Journal of Applied Statistics / v.24, no.4, 2011 , pp. 633-646 More about this Journal
Abstract
Clinical vaccines studies (that include cancer prevention vaccines and therapeutic vaccines) are ongoing to improve the quality of life and lengthen the human lifespan. Recently clinical trials and research on vaccines have become more active due to the prevalence of new viruses such as the A(H1N1) virus that freighted the whole word in 2009. In this paper we will describe the statistical aspects of clinical vaccine trials and outline the current situation of domestic and international vaccine development.
Keywords
Vaccine; clinical trials; sample size;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Miettinen, O. and Nurminen, M. (1985). Comparative analysis of two rates, Statistics in Medicine, 4, 213-226.   DOI   ScienceOn
2 Nauta, J. (2006). Statistical analysis of influenza vaccine lot consistency studies, Journal of Biopharma- ceutical Statistics, 16, 443-452.
3 Peduzzi, P., Donta, S. and Iwane, M. (1997). A Review of the design of vaccine efficacy trials and a proposal for the Design of the VA Cooperative study of active immunotherapy of HIV infection, Controlled Clinical Trials, 18, 397-419.   DOI   ScienceOn
4 한국과학기술정보연구원 (2006). <국가필수예방백신의 안정적공급을 위한 국가적 관리체계 구축>, 식품의약품안전청 연구보고서.
5 Chan, I. S. F., Bohidar, N. R. (1998). Exact power and sample size for vaccine efficacy studies, Communi- cations in Statistics Part A-Theory Methods, 27, 1305-1322.   DOI   ScienceOn
6 Ewell, M. (1996). Comparing methods for calculating confidence intervals for vaccine efficacy, Statistics in Medicine, 15, 2379-2392.   DOI   ScienceOn
7 FDA (2010). Guidance for Industry Non-inferiority clinical trials, Draft guidance
8 Gilbert, P. B. (2000). Some statistical issues in the design of HIV-1 vaccine an treatment trials, Statistical Methods in Medical Research, 9, 207-229.   DOI
9 Horne, A. D., Lachenbruch, P. A., Geston, P. R. and Hsu, H. S. (2001a). Analysis of studies to evaluate immune response to combination vaccines, Clinical Infectious Disease, 33, S306-311.   DOI   ScienceOn
10 Gilbert, P. B. (2010). Some design issues in phase 2B vs pahse 3 prevention trials for testing efficacy of products or concepts, Statistics in Medicine, 29, 1061-1071.   DOI   ScienceOn
11 Horne, A. D., Lachenbruch, P. A. and Goldenthal, K. L. (2001b). Intent-to-treat analysis and preventive vaccine efficacy, Vaccine, 19, 319-326.
12 Jovanovic, B. D. and Levy, P. S. (1997). A look at the rule of three, The American Statistician, 51, 137-139.   DOI
13 Lachenbruch, P. A. (1998). Sensitivity, specificity, and vaccine efficacy, Controlled Clinical Trials, 19, 569- 574.   DOI   ScienceOn
14 Lydia, A. F., Arciniega, J. and McVittie, L. (2001). Manufacturing issue with combining different antigens: A regulatory perspective, Clinical Infectious Diseases, 33, 351-355.   DOI   ScienceOn
15 식품의약품안전청 (2006). <백신의 임상평가시 고려사항>, 식품의약품안전청.
16 강승호 (2002). 정확검정들에 대한 고찰, <응용통계연구>, 15, 187-199.   DOI
17 강승호 (2010). <신약개발에 필요한 의학통계학>, 자유아카데미.
18 식품의약품안전청 <백신.BT정보방>, 식품의약품안전청.
19 식품의약품안전청 (2007). <백신의 임상평가시 고려사항 2007>, 식품의약품안전청.
20 식품의약품안전청 (2009a). <백신안전사용을 위한 핸드북>, 식품의약품안전청.
21 식품의약품안전청 (2009b). <약무행정(허가.심사) 용어해설집>, 식품의약품안전청.