SESSION KEYNOTE

Title : COVID 19 Vaccine Trials and Related Data Monitoring Issues by Susan Ellenberg, University of Pennsylvania
Speaker:
Susan Ellenberg, University of Pennsylvania 
Moderator:
Ivan S. F. Chan

Abstract:

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Instructors’ Biography:

Dr. Ellenberg’s research has focused on practical problems and ethical issues in designing, conducting and analyzing data from clinical trials, including surrogate endpoints, data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. At Penn, in addition to her teaching and administrative duties she serves as senior statistician for several multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research.  She chairs the organizing committee for the annual Penn conference on statistical issues in clinical trials. She also served for many years as Associate Dean for Clinical Research, overseeing the human subjects protections programs, training and centralized research support of the Perelman School of Medicine.

Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004, she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982-1988).

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