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Activity Details
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
