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Contributed Papers

Decision Frameworks — Go/No-Go & Probability of Success

Wed, Aug 5, 10:30 AM - 12:20 PM Room CC-206B Thomas M. Menino Convention & Exhibition Center

Sergei LeonovChair

Biopharmaceutical Section

7 Presentations

Accounting for Phase 2 Uncertainty in Phase 3 Sample Size Determinations: A Review of Approaches

10:35 AM - 10:50 AM

Zijiang Yang (Johnson and Johnson)

Co-authors: Koji Masuda

Sample size determination Assurance Power analysis Phase 3 clinical trial planning Quantile-based methods Probability of success

Bayesian Hybrid Lalonde Framework for Go/No-Go Decision-Making by Incorporating Historical Data

10:50 AM - 11:05 AM

Co-authors: Philip He (Daiichi Sankyo Inc.), Haiming Zhou (Daiichi Sankyo, Inc.)

Bayesian Hybrid Clinical Design Lalonde Go/No-Go Framework Generalized Self-Adaptive Mixture Prior Power Prior Objective Response

Considerations on applying decision guiding framework with multiple endpoints

11:05 AM - 11:20 AM

Co-authors: Jing Zhou (Novo Nordisk)

Decision guiding framework Phase 2 clinical study Multiple endpoints

Enhancing Go/No-Go Decision Making by Borrowing External Placebo Data

11:20 AM - 11:35 AM

Sherry Xu (CSL Behring)

Co-authors: Yiyao Shi (University of California, Irvine), Michael Fries (CSL Behring)

Early development Go / No-Go Information borrowing Meta-analytic predictive (MAP) prior

Predicting the Probability of Success for a Phase III Trial by Phase II Trial and real-world data

11:35 AM - 11:50 AM

Zhengfan Wang (Genesis Research)

Co-authors: Bret Zeldow, Jolyon Faria (AstraZeneca), Jessica Davies (AstraZeneca), Abhijit Dasgupta (AstraZeneca), Craig Parzynski (Genesis Research Group)

Bayesian Inference real-world evidence g-computation multiple imputation transporting

Quantifying the value of extended follow-up in proof-of-concept trials for decision-making

11:50 AM - 12:05 PM

Angela Zhu (Boehringer Ingelheim)

Co-authors: Kevin Kunzmann (Boehringer Ingelheim), Na Hu (Boehringer Ingelheim), Carina Ittrich (Boehringer Ingelheim Pharma GmbH & Co. KG), Susan Wang (Boehringer Ingelheim Pharmaceutical, Inc.)

proof-of-concept clinical development simulation go/no-go decision-making

Using Bayesian Dynamic Borrowing for Quantitative Evaluation in Go/No Go Decision Framework

12:05 PM - 12:20 PM

Runzhi Zhang (AbbV)

Co-authors: Tina Young (AbbVie), Haiwei Zhou, Mei Li (AbbVie)

Bayesian dynamic borrowing Robust mixture prior Go/No-Go Decision

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