The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
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Group sequential testing methods for comparing cure rates

임상시험에서 치료율 비교를 위한 집단축차검정법에 관한 고찰

  • 박경미 ((130-650) 서울 청량우체국 사서함 255호, 과학기술정책관리연구소 위촉연구원) ;
  • 이재원 ((136-701) 서울시 성북구 안암동 5-1, 고려대학교 통계학과)
  • Published : 1996.09.01
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Abstract

There are many clinical trials where a large portion of the patients are cured of disease. In such a case, one might be more interested in testing the differences in cure rates rather than other types of differences in failure distribution. For ethical and economic reasons, clinical trials must be repeatedly monitored for evidence of treatment benefit or harm. In this article, we examined by simulation the properties of nonparametric group sequential methods for comparing the cure rates between two treatment groups during the trial in a wide range of alternatives, censoring rates and cure rates.

의약학 분야에 있어서 임상시험(clinical trial)을 하는 도중에 약의 독성이 발견되거나 연구 초기에 두 처리군간의 차이가 크게 나타난다면 임상시험의 종료를 신중하게 고려하는 것이 바람직할 것이다. 따라서 요즈음에는 일정시간이 경과할 때마다 실험 결과를 중간점검(interim monitoring)하는 것이 점점 요구되어지고 있는 추세다. 본 논문에서는 두 치료법의 치료율을 비교하는 경우에 비모수검정통계량에 집단축차검정법을 적용하여 생존분포, 치료율, 중도절단율, 오류분배율함수(error spencing rate function) 등을 다양하게 변화시키면서 모의실험을 실시하여 Gray-Tsiatis 통계량, logrank 통계량, Gehan 통계량 각각에 대한 검정력과 유의수준을 비교하였다.

Keywords

References

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