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Contributed Papers

Improving Data-Driven Clinical Decisions: Quantitative Approaches for Success

Tue, Aug 5, 10:30 AM - 12:20 PM Room CC-104E Music City Center

Hongwei WangChair

Biopharmaceutical Section

7 Presentations

Clinical Trials for New Drug Development: Optimal Investment and Application

10:35 AM - 10:50 AM

Co-authors: Hong Li (University of California, Davis), Zhili Tian (University of Houston), Hong Li (University of California, Davis)

pharmaceutical drug development clinical trial R&D project management optimal investment

Conditional Power: The Good, The Bad (and The Ugly?)

10:50 AM - 11:05 AM

Co-authors: Keaven Anderson (Merck & Co., Inc.), Keaven Anderson (Merck & Co., Inc.)

conditional power interim analysis group sequential design adaptive design

Dual-criterion Dose Finding Designs Based on Dose-Limiting Toxicity and Tolerability

11:05 AM - 11:20 AM

Co-authors: Yunlong Yang, Yunlong Yang

Phase I trials Bayesian design Dose optimization

Evaluating Clinical Utility for Composite Hypothesis with Efficacy and Safety in Trial Design

11:20 AM - 11:35 AM

Co-authors: Gaurav Sharma (Takeda Pharmaceuticals), Gaurav Sharma (Takeda Pharmaceuticals), Jackie Wu (Takeda Pharmaceuticals), bo zhang

Composite endpoint Clinical Trial Design Binary Endpoint

Head-to-head Comparison Using Data Integration of Summary Data via Generalized Entropy Balancing

11:35 AM - 11:50 AM

Co-authors: Kotaro Mizuma (The University of Osaka), Kotaro Mizuma (The University of Osaka), Kosuke Morikawa

Indirect comparison Summary-level data Data integration Generalized entropy balancing

Leveraging Mendelian Randomization for Drug Development: A Case Study using Epiregulin Antagonist

11:50 AM - 12:05 PM

Co-authors: Zhangchen Zhao (Eli Lilly and Company), Zhangchen Zhao (Eli Lilly and Company)

Mendelian Randomization Polyneuropathic Pain Diabetic Peripheral Neuropathic Pain Epiregulin Antagonist Clinical Trial Design

Optimizing Binary Endpoint Analysis: A Quantitative Framework for Enhanced Clinical Trial Success

12:05 PM - 12:20 PM

Co-authors: Nicholas DeVogel (AbbVie), Liu Meng (AbbVie), Nicholas DeVogel (AbbVie), Weihan Zhao (AbbVie), Su Chen (Abbvie), Lei Shu (AbbVie), Yang Yang (AbbVie)

Binary endpoints Cochran-Mantel-Haenszel (CMH)Mantel-Haenszel (MH) estimation Miettinen and Nurminen (MN)

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