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Contributed Papers

Use of External Control in Clinical Trial Design

Tue, Aug 6, 10:30 AM - 12:20 PM

Prosenjit KunduChair

Biopharmaceutical Section

7 Presentations

A Bayesian Hybrid Phase 2 Design With Borrowing from Historical Control Study of Monotherapy

10:35 AM - 10:50 AM

Philip He (Daiichi Sankyo Inc.)

Co-authors: Zhaohua Lu (Daiichi Sankyo Inc), Girma Ayele, John Toso (Daiichi Sankyo)

Bayesian dynamic power prior borrowing for augmenting a control arm for survival analysis

10:50 AM - 11:05 AM

Sanhita Sengupta (Bristol Myers Squibb)

Co-authors: Jixian Wang (Bristol Myers Squibb), Ram Tiwari (Bristol Myers Squibb)

Bayesian group-sequential adaptive randomization design incorporating data from external controls

11:05 AM - 11:20 AM

Yusuke Yamaguchi (Astellas Pharma Global Development, Inc.)

Borrowing Study-Level Historical Longitudinal Control Data for Generalized Linear Mixed-effects Mode

11:20 AM - 11:35 AM

Co-authors: Tsung-Chin Wu (UC San Diego, Department of Family Medicine & Public Health), Hong Li (Takeda), Jovanna Baptista (Takeda), Joseph Gao (Takeda Pharmaceuticals)

Estimating Long-term Treatment Effect in Open-label Extension (OLE) Phase using External Controls

11:35 AM - 11:50 AM

Co-authors: Herbert Pang (Genentech/Roche), Christiana Drake (Department of Statistics, University of California Davis), Hans Ulrich Burger (Hoffmann-La Roche), Jiawen zhu (Genentech, Inc.)

External Control Interim Data Borrowing in Clinical Trials

11:50 AM - 12:05 PM

Co-authors: Atalanta Ghosh (Johnson & Johnson), Yun Shen (University of California, Riverside), Lisa Neums (Boehringer Ingelheim)

Regulatory and statistical considerations for incorporating external controls in single arm trials

12:05 PM - 12:20 PM

Angela Zhu (Johnson & Johnson)

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