Usage of Statistics in Clinical Trials

임상시험에서의 통계 활용

  • Ahn, Hong-Yup (Department Statistics, Dongguk University-Seoul)
  • 안홍엽 (동국대학교-서울 통계학과)
  • Published : 2010.03.01

Abstract

The purpose of clinical trials is to find evidences for the effects of experimental new drugs or treatments on human. For the successful clinical trials, it is not sufficient to use statistics only for the analyses of collected data, but it is necessary to extend the usage of statistics in various ways. At the beginning of the study, one needs to use statistics for systematically and concretly planning the study. For this, we discussed the usage of statistics in defining the effect, determining the sample size, statistical analyses, and so on.

임상시험은 인간을 대상으로 약물 또는 치료법의 효과를 검증하는 것을 목적으로 하고 있다. 성공적인 임상시험을 위해서는 단순한 자료분석에만 통계의 이용을 제한하지 않고 다양한 영역으로 활용의 폭을 넓히는 것이 필요하다. 연구계획단계에서부터 구체적이고 체계적으로 통계의 활용을 고려하기 위해 효과에 대한 정의, 적정한 표본크기 산정, 통계분석 방법 등 전반적인 통계의 응용을 고찰한다.

Keywords

References

  1. Willcox WF. The founder of statistics. Rev Int Stat Ins 1938; 5(4):321-8. https://doi.org/10.2307/1400906
  2. Wikipedia.org [Internet]. Statistics; c2008 [cited 2010 Jan 13]. Available from: http://en.wikipedia.org/wiki/Statistics#cite_note-9.
  3. Ederer F. The statistician's role in developing a protocol for a clinical trial. Am Stat 1979;33(3):116-9. https://doi.org/10.2307/2683811
  4. Bearman JE. Randomized controlled clinical trial. National Eye Institute workshop for ophthalmologists. Writing the protocol for a clinical trial. Am J Ophthalmol 1975;79(5):775-8. https://doi.org/10.1016/0002-9394(75)90736-9
  5. Kaku DA, Lowenstein DH. Emergence of recreational drug abuse as a major risk factor for stroke in young adults. Ann Intern Med 1990;113(11):821-7. https://doi.org/10.7326/0003-4819-113-11-821
  6. Steering Committee of the Physicians' Health Study Research Group. Final report on the aspirin component of the ongoing Physicians' Health Study. N Engl J Med 1989;321(3):129-35. https://doi.org/10.1056/NEJM198907203210301
  7. Dawson B, Trapp RG. Basic & clinical biostatistics. 3rd ed. New York:McGraw-Hill;2001.
  8. Parker RA, Berman NG. Sample size: more than calculations. Am Stat 2003;57(3):166-70. https://doi.org/10.1198/0003130031919
  9. Oh HB, Ahn HY, Lee KJ, Hwang SH, Choi SE, Lee HJ. Clinical evaluation of diagnostic medicines. Seoul:Korea Medical Book; 2007.