Simon の 2 段階法原理　検出力

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

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)<αr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 • 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 TrialsCo-Chairs: Vered Stearns, MD – Johns Hopkins Oncology CenterSusan G. Hilesenbeck, PhD – Lester and Sue Smith Breast Center at Baylor College of Medicine • OverviewSusan G. Hilsenbeck, PhD – Lester and Sue Smith Breast Center at Baylor College of MedicineVered Stearns, MD – Johns Hopkins Oncology CenterChallenges in Transporting Multi-Gene Classifiers to the ClinicLara Lusa, PhD – University of Ljubljana, SloveniaStatistical Consideration for Incorporating Biomarkers into TrialsGary M. Clark, PhD – Array BioPharma • Prospective Germline Pharmacogenetic Testing for Irinotecan and 5-FluorouracilFederico Innocenti, MD, PhD – University of ChicagoReproducible Research/SignaturesChristos Sotiriou, MD, PhD - Institut Jules BordetPanel Discussion: When is a Marker Ready for Trial?Led by moderators and Christos Sotiriou, MD, PhD

Simon の 2 段階法原理　検出力