The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
권호 표지
DOI QR코드

DOI QR Code

Statistical Consideration of Vaccine Clinical Trials

백신임상시험에 대한 통계적 고찰

  • Nam, Ju-Sun (Department of Statistics, Ewha Womens University, Biopharmaceutical Policy Division, KFDA) ;
  • Kang, Seung-Ho (Department of Applied Statistics, Yonsei University)
  • 남주선 (이화여자대학교 통계학과, 식품의약품안전청 바이오의약품정책과) ;
  • 강승호 (연세대학교 응용통계학화)
  • Received : 20110400
  • Accepted : 20110700
  • Published : 2011.08.31
Download PDF
⟨ Previous Next ⟩

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.

인류의 평균수명 연장과 삶의 질 향상을 위해서 암 예방을 위한 백신 뿐 아니라 치료를 위한 백신 등 백신에 대한 많은 연구가 진행되고 있다. 또한 2009년 전 세계를 공포로 몰았던 신종인플루엔자 등 신종바이러스 유행으로 백신에 대한 임상시험과 연구는 더욱더 활기를 띄게 되었다. 본 논문에서는 백신에 대한 임상시험에서 고려해야할 통계학적인 부분에 대해 기술하고, 현재 우리나라를 포함한 전 세계적인 백신의 개발 현황에 대해서도 언급하겠다.

Keywords

References

  1. 강승호 (2002). 정확검정들에 대한 고찰, <응용통계연구>, 15, 187-199. https://doi.org/10.5351/KJAS.2002.15.1.187
  2. 강승호 (2010). <신약개발에 필요한 의학통계학>, 자유아카데미.
  3. 식품의약품안전청 <백신.BT정보방>, 식품의약품안전청.
  4. 식품의약품안전청 (2006). <백신의 임상평가시 고려사항>, 식품의약품안전청.
  5. 식품의약품안전청 (2007). <백신의 임상평가시 고려사항 2007>, 식품의약품안전청.
  6. 식품의약품안전청 (2009a). <백신안전사용을 위한 핸드북>, 식품의약품안전청.
  7. 식품의약품안전청 (2009b). <약무행정(허가.심사) 용어해설집>, 식품의약품안전청.
  8. 한국과학기술정보연구원 (2006). <국가필수예방백신의 안정적공급을 위한 국가적 관리체계 구축>, 식품의약품안전청 연구보고서.
  9. 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. https://doi.org/10.1080/03610929808832160
  10. Ewell, M. (1996). Comparing methods for calculating confidence intervals for vaccine efficacy, Statistics in Medicine, 15, 2379-2392. https://doi.org/10.1002/(SICI)1097-0258(19961115)15:21<2379::AID-SIM457>3.0.CO;2-L
  11. FDA (2010). Guidance for Industry Non-inferiority clinical trials, Draft guidance
  12. 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. https://doi.org/10.1177/096228020000900303
  13. 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. https://doi.org/10.1002/sim.3676
  14. 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. https://doi.org/10.1086/322566
  15. Horne, A. D., Lachenbruch, P. A. and Goldenthal, K. L. (2001b). Intent-to-treat analysis and preventive vaccine efficacy, Vaccine, 19, 319-326.
  16. Jovanovic, B. D. and Levy, P. S. (1997). A look at the rule of three, The American Statistician, 51, 137-139. https://doi.org/10.2307/2685405
  17. Lachenbruch, P. A. (1998). Sensitivity, specificity, and vaccine efficacy, Controlled Clinical Trials, 19, 569- 574. https://doi.org/10.1016/S0197-2456(98)00042-7
  18. Lydia, A. F., Arciniega, J. and McVittie, L. (2001). Manufacturing issue with combining different antigens: A regulatory perspective, Clinical Infectious Diseases, 33, 351-355. https://doi.org/10.1086/322579
  19. Miettinen, O. and Nurminen, M. (1985). Comparative analysis of two rates, Statistics in Medicine, 4, 213-226. https://doi.org/10.1002/sim.4780040211
  20. Nauta, J. (2006). Statistical analysis of influenza vaccine lot consistency studies, Journal of Biopharma- ceutical Statistics, 16, 443-452.
  21. 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. https://doi.org/10.1016/S0197-2456(97)00026-3