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Topic-Contributed Paper Session

Recent advance in design and analysis in clinical trials when the proportional hazard assumption is impossible to hold

Thu, Aug 7, 8:30 AM - 10:20 AM Room CC-210 Music City Center

Hajime UnoOrganizerZhenzhen XuOrganizerLu TianChair

Biopharmaceutical Section co: Lifetime Data Science Sectionco: No Additional Sponsor Applied

5 Presentations

Blinded sample-size re-estimation for the restricted mean survival time via the worst-case variance evaluation using mathematical programming

8:35 AM - 8:55 AM

Satoshi Hattori (Osaka University)

Blinded sample size re-estimation Nonproportional hazards Non-linear programing Restricted mean survival time

Survival Analyses without Risk Stratification Can Induce Non-Proportional Hazard Conditions

8:55 AM - 9:15 AM

Devan Mehrotra (Merck & Co., Inc.)

5-STAR algorithm average hazard ratio conditional inference tree elastic net risk stratification

Semiparametric piecewise-accelerated failure time model for immune-oncology clinical trials

9:15 AM - 9:35 AM

Hisato Sunami (Kyowa Kirin Co., Ltd.)

Accelerated failure time model Immune-oncology clinical trials Proportional hazard Semiparametric estimation Survival tree

Group sequential designs using average hazard with survival weight for clinical trials

9:35 AM - 9:55 AM

Hajime Uno (Dana-Farber Cancer Institute)

Evaluating treatment effect adjusting for multiple overlapping subgroups under non-proportional hazards patterns

9:55 AM - 10:15 AM

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