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Contributed Speed

SPEED 9: Statistics with Applications to Biopharmaceuticals, Mental Health, and Medical Devices, Part 1

Wed, Aug 9, 8:30 AM

Andriy DerkachChair

Biopharmaceutical Section co: Mental Health Statistics Sectionco: Section on Medical Devices and Diagnostics

17 Presentations

Incorporating Interventions to a SEIRD Model with Vaccination: Application to COVID-19 in Qatar

8:35 AM - 8:40 AM

Elizabeth Amona (Virginia Commonwealth University)

Co-authors: Edward Boone (Virginia Commonwealth University), Ryad Ghanam (Virginia Commonwealth University in Qatar), Indranil Sahoo (Virginia Commonwealth University), Laith Abu-Raddad (Well Cornell Medical College, Qatar)

A Simulation Study Based on Historical Control Data for Long-Term Carcinogenicity Studies

8:40 AM - 8:45 AM

Jing Yu (Merck)

Co-authors: Nana Wang (NA), Richard Baumgartner (Merck Research Laboratories), Dan Holder (NA)

Calculation of Phase 2 Dose-Finding Study Sample Size for Reliable Phase 3 Dose Selection

8:45 AM - 8:50 AM

Qing Zhao (Merck & Co., Inc.)

Co-authors: Fang Liu, Anthony Rodgers (Merck & Co., Inc.), Devan Mehrotra (Merck & Co., Inc.)

Algorithms to Identify Linear Dynamic Range of Calibration Curve

8:50 AM - 8:55 AM

Charles Tan (Pfizer)

Co-authors: Andrew McKeen

Surrogate Endpoint Development for CKD/DKD

8:55 AM - 9:00 AM

Yinghua Zhang (Johnson & Johnson)

Co-authors: George Capuano (Johnson & Johnson-Janssen R&D)

Confidence Interval Estimation for the Desirability of Outcome Ranking Probability

9:00 AM - 9:05 AM

Yijie He

Co-authors: Toshimitsu Hamasaki (George Washington University), Scott Evans (George Washington University)

A Family of Modified Huber Loss Functions for Continual Reassessment Methods in Clinical Trials

9:05 AM - 9:10 AM

Ling Zhang (University of Iowa)

Co-authors: Emine Bayman, Gideon Zamba (University of Iowa)

Analyzing log transformed data with demo on simulated data and step by step interpretation with SAS

9:10 AM - 9:15 AM

Jie Cui

Psborrow2: an R package for complex, innovative trial designs using Bayesian dynamic borrowing

9:15 AM - 9:20 AM

Matthew Secrest (Genentech)

Co-authors: Isaac Gravestock, Jiawen Zhu (Genentech, Inc.), Herbert Pang, Daniel Sabanes Bove (Roche)

On the Use of Historic Data to Determine Standard Deviation

9:30 AM - 9:35 AM

Dongmei Lan (Astrazeneca/Cytel)

Co-authors: Dongmei Lan, Seth Seegobin (Astrazeneca), Brett Jepson (Cytel), Kathryn Shoemaker (Astrazeneca), Daniel Meddings (Astrazeneca)

The impact of binding and non-binding stopping rules on futility analysis in group sequential design

9:35 AM - 9:40 AM

Jun He (BMS)

Co-authors: Gengyuan Liu (BMS), Jerry Li (BMS)

Leveraging advanced statistical monitoring methods in neuroscience trials

9:40 AM - 9:45 AM

Rakhi Kilaru (Pharmaceutical Product Development)

Co-authors: Andrew Hartley (PPD, Part of Thermo Fisher Scientific), Martin Brown (PPD, part of ThermoFisher Scientific), Yudong Zhao (PPD, part of Thermo Fisher Scientific), Dorota Nieciecka (PPD, part of Thermo Fisher Scientific)

Beyond estimand specification: Considerations for estimand-aligned estimation

9:45 AM - 9:50 AM

Suzanne Dufault

Co-authors: Isabelle Weir (Harvard School of Public Health), Nancy Hills (UCSF), Patrick Phillips (University of California, San Francisco)

Alternative methods to better handle influencers in rare disease clinical trials

9:50 AM - 9:55 AM

Tianyue Zhou

Co-authors: Yi Wang (Tech Data), Lin Wang (Sanofi), Hui Quan (Sanofi), Xun Chen (Sanofi)

Approaches for Extending and Evaluating Multiple Imputation for Functional Data

10:00 AM - 10:05 AM

Adam Ciarleglio (George Washington University)

Estimating confidence intervals for predictive values via the ratio of two binomial proportions