Contributed Poster Presentations: Biopharmaceutical Section -- JSM 2023

Co-authors: Terri Swanson (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Sana Ghafoor (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Andrew Messere (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Bunmi Williams (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Jessica Selig (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Emma Jost-Price (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Anna Gao (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Michael Lubke (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), Theresa Tuthill (Digital Science & Translational Imaging, Pfizer Worldwide Research & Development), F. Isik Karahanoglu (Pfizer Global Research and Development)

21 Exact unconditional tests based on the MCP-Mod method for binary endpoints

JINGTAO ZHU

Co-authors: Gregory Wilding (University At Buffalo)

22 External Controls in Clinical Trials – Robust MAP Approach applied to phase II CD study

Maria Kudela

Co-authors: Anindita Banerjee (Pfizer), Satrajit Roychoudhury (Pfizer), Mark Whitlock (Pfizer)

23 Going beyond the TLFs: The importance of clear communication around statistics

Kimberly Knapik

24 Impact of Hyperprior Choice for Bayesian Dynamic Borrowing via a Normalized Power Prior

Emma Mackay (Cytel)

Co-authors: Aaron Springford

25 Meta-analysis application to hERG safety evaluation in clinical trials

Dalong Huang (FDA/CDER)

Co-authors: Xutong Zhao (FDA), Jing Sun (FDA/CDER)

26 MMRM and GEE for continuous outcomes: An assessment based on three phase 3 trials in rare diseases

David Zahrieh (Ultragenyx)

Co-authors: Yi Wang (Ultragenyx Pharmaceutical), Tony Koutsoukos (Ultragenyx Pharmaceutical)

27 Multilevel Prioritized Composite Data Application of Mao's Proportional Win Fractions Regression

Luke Zheng

Co-authors: Gheorghe Doros (Boston University)

28 Non-parametric approach to predict recruitment for randomized CT in elderly inpatient setting

Alejandro Villasante Tezanos (University of Texas Medical Branch)

Co-authors: Yong-Fang Kuo (University of Texas, Medical Branch), Xiaoying Yu (University of Texas Medical Branch at Galveston)

29 Overview of Vaccine Efficacy Trial Design With Early Stopping

Ying Zhang (Merck & Co., Inc.)

Co-authors: Jun Park (Biostatistics and Research Decision Sciences, Merck & Co., Inc.), Yaru Shi

30 Penalized regression models for improved propensity score estimation in unbalanced treatment arms

Deepak Nag Ayyala (Takeda Pharmaceuticals)

Co-authors: Cassie Dong

31 Placebo-Response Mitigation: Design for potential increased Statistical Power

Lance Ballester (Lotus Clinical Research)

Co-authors: Erin Tireman (Lotus Clinical Research), William Martin (Lotus Clinical Research), Neil Singla (Lotus Clinical Research), Timothy Rogier (Lotus Clinical Research)

32 Practical Considerations and Applications of Master Protocols

Danny Lu

33 Practical Uncertainty Quantification Methods for QSAR

Yuting Xu (Merck Sharp & Dohme)

Co-authors: Andy Liaw (Merck & Co., Inc.), Vladimir Svetnik (Merck & Co., Inc.)

34 Promising Zone Adaptations in Proof of Concept Trials

Mitch Wassom (Pentara)

Co-authors: Jessie Nicodemus-Johnson (Pentara), Suzanne Hendrix (Pentara Corporation), Samuel Dickson (Pentara)

35 Setting Expectations for Formal Interim Analyses with Data Monitoring Committees

Emily Woolley (Axio, a Cytel company)

36 Statistical Inference for Response-Adaptive Randomization Designs: A Comparative Study

Xue Yang (University of Pittsburgh)

Co-authors: Yu Cheng (University of Pittsburgh), Abdus Wahed (University of Rochester)

41 Weighting-augmented regression adjustment for indirect comparisons under data access constraints

Chengyang Gao

Co-authors: Gianluca Baio (University College London), Anna Heath (Hospital for Sick Children/ University of Toronto)

WITHDRAWN 20 Event monitoring based on survival trees

Co-authors: Li He (Merck Research Laboratories)

WITHDRAWN 37 Subgroup Analyses in Clinical Trials based on The Desirability of Outcome Ranking (DOOR)

Co-authors: Weixiao Dai, Toshimitsu Hamasaki (George Washington University), Scott Evans (George Washington University), Ionut Bebu (George Washington University)

WITHDRAWN Bayesian Adaptive Enrichment Design for Continuous Biomarkers

Yue Tu

Co-authors: Lindsay Renfro (Univ. of Southern California and Children's Oncology Group)

WITHDRAWN The impact of CDx measurement performance on clinical trials with different types of outcomes

Co-authors: Xiaoyu Zhang, Hong Wang (Sanofi), Wenting Wang (Sanofi), Yuh-Jenn Wu (Chung Yuan Christian University), Michael LaValley (Boston University), Ching-Ti Liu (Boston University School of Public Health)

WITHDRAWN the unintended consequences of collapsing clinical scales to 'clinically meaningful' point separation

Co-authors: Newman Knowlton, Sean Hennessey (Pentara), Jessie Nicodemus-Johnson (Pentara), Suzanne Hendrix (Pentara Corporation), Samuel Dickson (Pentara)

WITHDRAWN Two-stage Pick-the-winner Sequential Parallel Comparison Design

Co-authors: Yuting Yang (University of Florida), Shangwu Wu (University of Florida)

Contributed Poster Presentations: Biopharmaceutical Section

40 Presentations