Survival Analysis in Clinical Trials: Innovative Methods and Applications

Sun, Aug 3, 2:00 PM - 3:50 PM Room CC-208A Music City Center

Moming LiChair

Biopharmaceutical Section

6 Presentations

A New Approach for Non-Inferiority Assessment Using MLR Test Under Cox's PH Model Setting

2:05 PM - 2:20 PM

Co-authors: Kallappa Koti (FDA (Retired)), Kallappa Koti (FDA (Retired))

Partial likelihhod Observed information matrix Lognormal distribution Lindeberg's CLT

An optimal dynamic treatment regime estimator for indefinite-horizon survival outcomes

2:20 PM - 2:35 PM

Co-authors: Jane She, Matthew Egberg (Department of Pediatrics, Division of Pediatric Gastroenterology, University of North Carolina Schoo), Jane She, Michael Kosorok (University of North Carolina at Chapel Hill)

precision medicine survival analysis dynamic treatment regimes random forests

Estimation of Restricted Mean Time in Favor of Treatment: A Novel Method for Multi-State Models

2:35 PM - 2:50 PM

Co-authors: Mohsen Rezapour Toughari, Mohsen Rezapour Toughari

Clinical trials composite endpoints estimands recurrent events restricted mean survival time

Noninferiority trial design with survival outcome for nonproportional hazards with Relative Time

2:50 PM - 3:05 PM

Co-authors: Geethanjalee Mudunkotuwa (University of Kansas Medical Center, KS), Milind Phadnis (University of Kansas Medical Center), Geethanjalee Mudunkotuwa (University of Kansas Medical Center, KS)

Non-interiority Non-proportional hazards Relative time Time-to-event Weibull Clinical trials

Sample size calculations for time-to-event endpoints with extreme hazard ratios

3:05 PM - 3:20 PM

Co-authors: Kaifeng Lu, Kaifeng Lu

proportional hazards hazard ratio Schoenfeld formula power sample size simulation

WITHDRAWN: Tools for Randomized Clinical Trials Using Restricted Mean Survival Time and Average Hazard

3:20 PM - 3:35 PM

Co-authors: Miki Horiguchi (Dana-Farber Cancer Institute), Hajime Uno (Dana-Farber Cancer Institute)

non-proportional hazards survival analysis time-to-event outcomes clinical trials study design