SESSION KEYNOTE

Title: Clinical Trials in the Twenty-First Century: Challenges and Opportunities
Speaker : Professor Susan S. Ellenberg, UPenn
Moderator: Alfred H. Balch


Abstract:
The practice of clinical trials has evolved substantially in the 70+ years since the modern era of clinical trials was ushered in with randomized trials of streptomycin to treat tuberculosis.  Many trial designs and new methods of analysis have been developed to meet emerging needs, and many pitfalls in the early approaches to trial design, conduct and analysis have been recognized and methods developed to avoid them. But the clinical trials community faces many new challenges, such as using “real world data” to enhance the generalizability of results and lower trial costs; making optimal use of sophisticated imaging and mobile health technology; and engaging with attacks on our traditional inferential approaches.  These are interesting times for clinical trialists!

 

Speaker Bio

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).

Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute. She is the 2019 recipient of the Florence Nightingale David Award, a biannual award given jointly by the major North American statistical societies to a female statistician for outstanding achievements. The first edition of her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named Wiley Europe Statistics Book of the Year for 2002; a second edition was released in March 2019.

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