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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

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Simon の 2 段階法原理 検出力

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  1. 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

  2. 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

  3. 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

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