- Statistical Methods in Non-Inferiority Trials - A Focus on US FDA Guidelines -
- ㆍ 저자명
- Kang. Seung-Ho,Wang. So-Young
- ㆍ 간행물명
- 응용통계연구
- ㆍ 권/호정보
- 2012년|25권 4호|pp.575-587 (13 pages)
- ㆍ 발행정보
- 한국통계학회
- ㆍ 파일정보
- 정기간행물| PDF텍스트
- ㆍ 주제분야
- 기타
The effect of a new treatment is proven through the comparison of a new treatment with placebo; however, the number of parent non-inferiority trials tends to grow proportionally to the number of active controls. In a non-inferiority trial a new treatment is approved by proof that the new treatment is not inferior to an active control; however, both additional assumptions and historical trials are needed to show (through the comparison of the new treatment with the active control in a non-inferiority trial) that the new treatment is more efficacious than a putative placebo. The two different methods of using the historical data: frequentist principle method and meta-analytic method. This paper discusses the statistical methods and different Type I error rates obtained through the different methods employed.