All times are US Eastern Daylight Time (GMT-4). All events will start 10 mins before the scheduled times to allow the speakers and the participants to login.
Wednesday, March 29, 2023
| Time | Short Courses | # | Instructors |
|---|---|---|---|
| 9:00am – 12:00pm | Introduction to Bayesian Methods for Clinical Trial Design and Sample Size Determination | C1A | Joseph G. Ibrahim |
| Real World Evidence Framework in Clinical Development | C2 | Laura Fernandez, Freda Cooner | |
| Reproducible Data Analysis Pipelines in R | C3 | Will Landau | |
| Randomized Phase II Trials | C4 | Sin-Ho Jung | |
| 12:00pm – 1:00pm | Break | ||
| 1:00pm-4:00pm | Introduction to Bayesian Methods for Clinical Trial Design and Sample Size Determination | C1B | Joseph G. Ibrahim |
| Regulatory/Statistical Consideration of Biosimilar Product Development | C3 | Tom Gwise, Shein-Chung Chow | |
| Multi-Regional Clinical Trial | C4 | Bruce Binkowitz | |
| Artificial Intelligence in Health Research | C6 | Mark Chang |
Thursday, March 30, 2023
| Time | Session/Event | # | Organizers | |
|---|---|---|---|---|
| 9:00am – 10:30am | Opening Remarks and Keynote I |
John Concato | ||
| 10:30am – 10:45am | Break | |||
| 10:45am – 12:00pm (75mins) | Estimand in Oncology | SA1 | Jingjing Schneider, Qing Xu | |
| Patient Centric Trials | SA2 | Colleen Russell, Shuyen Ho | ||
| Software and Data Standardization and Integrity | SA3 | Fang Chen, Shibing Deng | ||
| Patient Centric Trials | SA4 | Fang Chen, Freda Cooner | ||
| Integrated Analysis of RCTs and Population-based Studies | S1E | Shu Yang | ||
| 12:00pm – 1:00pm | Poster Session | ???Ying Yang, Marlina Nasution | ||
| 1:00pm – 2:15pm (75mins) | Benefit Risk Assessment: Case Studies | SB1 | Anastasia Ivanova, Shibing Deng | |
| General Considerations for RWE/RWD Studies | SB2 | Qing Xu , Freda Cooner , Xiaofei Wang | ||
| Current Issues in Data Monitoring Committees: Moderated Panel Session | SB3 | Jingjing Schneider, Shibing Deng | ||
| Statistical Considerations for Rare Disease Clinical Trials | S2D | Yeh-Fong Chen, Freda Cooner, Jean Pan | ||
| Clinical Experience for Cancer Immunotherapy Trial Design | S2E | Anastasia Ivanova, Freda Cooner | ||
| 2:15pm – 2:30pm | Break | |||
| 2:30pm – 4:30pm (120mins) | Information Borrowing in Rare Disease and Non-Oncology Clinical Trials | SC1 | Rakhi Kilaru, Qiming Liao, Freda Cooner | |
| Data Monitoring Committee | SC2 | Marlina Nasution, Shuyen Ho, Robert Barrier | ||
| Centralized Statistical Monitoring Tools in Trial Conduct | SC3 | Rakhi Kilaru | ||
| Master Protocols | S3D | Miaomiao Ge, Freda Cooner, Anastasia Ivanova | ||
| Data Quality, Integrity and Risk Management Considerations in Clinical Trials | S3E | Rakhi Kilaru | ||
Friday, April 23, 2021
| Time | Session/Event | # | Speakers/organizers |
|---|---|---|---|
| 8:00am – 9:00am | Keynote II | Xiaofei Wang | |
| 9:00am – 9:15am | Break | ||
| 9:15am – 10:30am (75mins) | Leadership in Statistical Consulting | S4A | Alexander Schacht |
| Artificial Intelligence in Health Care Research | S4B | Xiaofei Wang | |
| Use of Companion Diagnostics (CoDx) in Clinical Trials | S4C | Sudhakar Rao | |
| Statistical Methodology for Cancer Immunology Trial Design | S4D | Jianrong Wu | |
| Biomarker-driven Trials with Adaptive Threshold Detection | S4E | Miaomiao Ge, Freda Cooner | |
| 10:30am – 10:45am | Break | ||
| 10:45am – 12:45pm (120mins) | Combination Therapy in Oncology Clinical Development | S5A | Freda Cooner, Qi Jiang, Anastasia Ivanova |
| Digital / Mobile Health in Clinical Trials | S5B | Kevin Anstrom | |
| Analytical and Methodological Challenges in the Study of Complex Liver Diseases | S5C | Ayako Suzuki | |
| Better Evidence Synthesis via Innovative Methods | S5D | Haitao Chu | |
| Interactive Visualization Tools | S5E | Richard Payne, Freda Cooner | |
| 11:45am – 2:30pm | Job Fair |