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412 * ! Wed, 8/5/2020, 1:00 PM - 2:50 PM Virtual
Incorporation of Real-World Evidence in Clinical Trial Designs and Associated Statistical Methodologies — Topic Contributed Papers
Section for Statistical Programmers and Analysts, Biopharmaceutical Section, Section on Statistical Learning and Data Science, Section on Statistical Computing
Organizer(s): Jeffrey Joseph, Covance; Swarna Reddy, Covance
Chair(s): Swarna Reddy, Covance
1:05 PM Using Real World Data to Evaluate the Generalizability of Evidence from Randomized Clinical Trials
Wei Shen, Eli Lilly and Company; Douglas Faries, Lilly Research Laboratories; Mark Belger, Eli Lilly and Company; Chen-Yen Lin, Eli Lilly and Company
1:25 PM Real World Evidence Use at CBER: Emerging Issues from Submissions
Jennifer Kirk, FDA, Center for Biologics Evaluation and Research (CBER)
1:45 PM Data Standardization to Facilitate Comparison of Real World Data and Clinical Trial Data
Aaron Galaznik, Acorn AI, a Medidata Company
2:05 PM Analytic Considerations for Constructing Real-World Control Arms
Katherine Tan, Flatiron Health; Brian Segal, Flatiron Health; Jonathan Bryan, Flatiron Health; Melissa Curtis, Flatiron Health; Nathan Nussbaum, Flatiron Health; Rebecca Miksad, Flatiron Health; Meghna Samant, Flatiron Health; Somnath Sarkar, Flatiron, Inc.; Aracelis Torres, Flatiron Health
2:25 PM Leverage Real World Evidence in Drug Development and Regulatory Decision Making
Rongmei Zhang, FDA, Center for Drug Evaluation and Research (CDER).
2:45 PM Floor Discussion