표제지
초록
ABSTRACT
목차
1장 서론 18
2장 연구 방법 20
2.1. 비열등성 임상시험 20
2.2. 집단 축차 비열등성 설계 20
1) Design strategy 21
2.3. 생존 자료에 대한 비열등성 검정을 위한 검정 통계량 26
2.4. 생존 자료에서 표본 수 계산 방법 26
1) Schoenfeld method 27
2) Extension of Schoenfeld method 28
3장 모의실험 & 사례연구 30
3.1. 모의실험 목적 30
3.2. 모의실험 설계 30
3.3. 모의실험 결과 평가 기준 31
3.4. 모의실험 결과 32
1) 경험적 제 1종 오류 크기 평가 32
2) 표본 수 32
3) 검정력 32
4장 고찰 70
5장 결론 72
참고문헌 74
Table 1. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.2 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 34
Table 2. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.2 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 35
Table 3. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.3 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 36
Table 4. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.3 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 37
Table 5. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.5 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 38
Table 6. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.5 and total analysis is 2, with inflation factor I(2, 0.05, 0.8) 39
Table 7. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.2 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 40
Table 8. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.2 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 41
Table 9. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.3 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 42
Table 10. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.3 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 43
Table 11. Estimated type 1 error(α) using Schoenfeld method(n), when combined probability=0.5 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 44
Table 12. Estimated type 1 error(α) using extension of Schoenfeld method(n), when combined probability=0.5 and total analysis is 3, with inflation factor I(3, 0.05, 0.8) 45
Table 13. Empirical power using Schoenfeld method when combined probability=0.2 and total analysis is 2 46
Table 14. Empirical power using extension of Schoenfeld method when combined probability=0.2 and total analysis is 2 47
Table 15. Empirical power using Schoenfeld method when combined probability=0.3 and total analysis is 2 48
Table 16. Empirical power using extension of Schoenfeld method when combined probability=0.3 and total analysis is 2 49
Table 17. Empirical power using Schoenfeld method when combined probability=0.5 and total analysis is 2 50
Table 18. Empirical power using extension of Schoenfeld method when combined probability=0.5 and total analysis is 2 51
Table 19. Empirical power using Schoenfeld method when combined probability=0.2 and total analysis is 3 52
Table 20. Empirical power using extension of Schoenfeld method when combined probability=0.2 and total analysis is 3 53
Table 21. Empirical power using Schoenfeld method when combined probability=0.3 and total analysis is 3 54
Table 22. Empirical power using extension of Schoenfeld method when combined probability=0.3 and total analysis is 3 55
Table 23. Empirical power using Schoenfeld method when combined probability=0.5 and total analysis is 3 56
Table 24. Empirical power using extension of Schoenfeld method when combined probability=0.5 and total analysis is 3 57
Figure 1. Schematic representation of group sequential non-inferiority trial strategy 1 24
Figure 2. Schematic representation of group sequential non inferiority trial strategy 2 25
Figure 3. Empirical type 1 error (k=2, combined probability=0.2, target type=1 error=0.05) 58
Figure 4. Empirical type 1 error (k=2, combined probability=0.3, target type=1 error=0.05) 59
Figure 5. Empirical type 1 error (k=2, combined probability=0.5, target type=1 error=0.05) 60
Figure 6. Empirical type 1 error (k=3, combined probability=0.2, target type=1 error=0.05) 61
Figure 7. Empirical type 1 error (k=3, combined probability=0.2, target type=1 error=0.05) 62
Figure 8. Empirical type 1 error (k=3, combined probability=0.5, target type=1 error=0.05) 63
Figure 9. Empirical power based on the log-rank test (k=2, combined probability=0.2) 64
Figure 10. Empirical power based on the log-rank test (k=2, combined probability=0.3) 65
Figure 11. Empirical power based on the log-rank test (k=2, combined probability=0.5) 66
Figure 12. Empirical power based on the log-rank test (k=3, combined probability=0.2) 67
Figure 13. Empirical power based on the log-rank test (k=3, combined probability=0.3) 68
Figure 14. Empirical power based on the log-rank test (k=3, combined probability=0.5) 69