Simonの2段階法原理 検出力
n1：stage1の例数、n2：stage2の例数、
r1：stage1における薬効棄却例数、
r ：Stage2における薬効棄却例数
p1期待奏功率
  B(r1, p1, n1) 
Min{r,n1)
 b(x, p1, n1)  B(r  x, p1, n2) (2)
xr11
Simonの2段階法原理
n1：stage1の例数、n2：stage2の例数、N=n1+n2
r1：stage1における薬効棄却例数、
r ：Stage2における薬効棄却例数
p0：閾値奏功率、p1期待奏功率、p*：観測
• 有意水準αの制約：r
Stage2で薬効が棄却 prob(p*|p0)<α rは下記を満たす数の最小値。
B(r, p0,N)< α (1)
•
検出力 1-βの制約
  B(r1, p1, n1) 
Min{r ,n1)

x r11
b( x, p1, n1)  B(r  x, p1, n2) (2)
• また、p0のもとNを最小にするような、r1、n1、すなわち
• N=n1+(1-B(r1,p0,n1))n2 を最小 (3)
• (1)、(2)、(3)を満たす、n1、n2、r1、rを決める
General Session III: Challenges Importing Biomarkers into Clinical Trials
Co-Chairs: Vered Stearns, MD – Johns Hopkins Oncology Center
Susan G. Hilesenbeck, PhD – Lester and Sue Smith Breast Center at Baylor College of Medicine
Overview
Susan G. Hilsenbeck, PhD – Lester and Sue Smith Breast Center at Baylor College of Medicine
Vered Stearns, MD – Johns Hopkins Oncology Center
Challenges in Transporting Multi-Gene Classifiers to the Clinic
Lara Lusa, PhD – University of Ljubljana, Slovenia
Statistical Consideration for Incorporating Biomarkers into Trials
Gary M. Clark, PhD – Array BioPharma
Prospective Germline Pharmacogenetic Testing for Irinotecan and 5-Fluorouracil
Federico Innocenti, MD, PhD – University of Chicago
Reproducible Research/Signatures
Christos Sotiriou, MD, PhD - Institut Jules Bordet
Panel Discussion: When is a Marker Ready for Trial?
Led by moderators and Christos Sotiriou, MD, PhD

FS -11302 FS 17875

Link Wettkampfplanung

心理学研究法I 第2回講義

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