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198 Mon, 8/8/2022, 2:00 PM - 3:50 PM CC-204A
Innovations in Patient-Focused Clinical Trials — Contributed Papers
Biopharmaceutical Section
Chair(s): John Han, J&J
2:05 PM Likelihood-Based Inferences for Hybrid Trials Incorporating Patient's Treatment Choice
Inmaculada A Aban, The University of Alabama at Birmingham; Rouba Chahine, RTI International
2:20 PM Innovative Basket Trails Design Using BIC (Bayesian Hierarchical Mixed Model, Patient Information, Clustering)
Chenyang Duan, Oregon State University ; Zheyu Liu, Bayer; Christoph Neumann, Bayer
2:35 PM Use and Potential Challenges of Consumer Wearable Devices in Clinical Trials
T. Paulette Ceesay, Merck & Co; Vladimir Svetnik, Merck Research Labs
2:50 PM Comparison of Estimand Strategies and Analysis Methods on Patient-Reported Outcome (PRO) Endpoint
Saijuan (Sandra) Zhang, Bristol Myers Squibb
3:05 PM A Comparison of K-Means and Consensus Clustering Algorithms in the Analysis of Wearable and Biosensor Data
Vanja Vlajnic, Bayer; Steve Simske, Colorado State University
3:20 PM Utility of Computerized Adaptive Testing for Measuring Endpoints in Clinical Trials
Fraser Bocell, US FDA/CDRH; Weimeng Weng, US FDA/CDER; Xin Yuan, US FDA/CDER; Kevin Weinfurt, Duke University
3:35 PM Approaches for Understanding Treatment Effects with Health Measures: The Meaningfulness of Expected Scores Versus Expected Differences in Scores
Laura Lee Johnson, U.S. Food and Drug Administration; Fraser Bocell, US FDA/CDRH; Monica Morell, U.S. Food and Drug Administration; Kevin Weinfurt, Duke University