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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

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

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