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9:00am – 10:30am |
Opening Remarks and Keynote I
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Shein-Chung Chow |
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10:30am – 10:45am |
Break |
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10:45am – 12:00pm (75mins) |
Benefit Risk Assessment: Methodology |
S1A |
Richard Payne, Yeh-Fong Chen |
Complex Innovative Designs (CID) Pilot Program |
S1B |
Freda Cooner |
Pediatric Clinical Development |
S1C |
Freda Cooner, Yeh-Fong Chen |
Simulation in Complex and Innovative Trials |
S1D |
Fang Chen, Freda Cooner |
Integrated Analysis of RCTs and Population-based Studies |
S1E |
Shu Yang |
12:00pm – 1:15pm |
Poster Session |
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Qing Yang, Marlina Nasution |
1:15pm – 3:15pm (120mins) |
Benefit Risk Assessment: Case Studies |
S2A |
Richard Payne, Yeh-Fong Chen |
General Considerations for RWE/RWD Studies |
S2B |
Qi Jiang, Jean Pan |
Current Issues in Data Monitoring Committees: Moderated Panel Session |
S2C |
Frank Rockhold, Susan Halabi, Marlina Naustion, Robert Barrier, Roann Seay |
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 |
3:15pm – 3:30pm |
Break |
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3:30pm – 5:30pm (120mins) |
Statistical Considerations for RWE/RWD Studies |
S3A |
Qi Jiang, Jean Pan |
Treatment, Prevention, Remission and Cure: Statistical Challenges and Advances in HIV Drug Development |
S3B |
Qiming Liao, Cliburn Chan |
ICH E9 (R1)-Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials |
S3C |
Yeh-Fong Chen, Rakhi Kilaru, Miaomiao Ge, Roann Seay |
Master Protocols |
S3D |
Miaomiao Ge, Freda Cooner, Anastasia Ivanova |
Data Quality, Integrity and Risk Management Considerations in Clinical Trials |
S3E |
Rakhi Kilaru |
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