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Tuesday, June 28 • 2:00pm - 3:15pm
#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics

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Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, we will discuss open-label, delayed-start studies and open-label extension studies that are conducted to evaluate safety and efficacy. A statistician will describe delayed-start study designs and an epidemiologist will discuss when such studies are needed, and the interpretation of study findings. An ethicist will identify the ethical aspects of these study designs and their conduct.

Learning Objectives

Explain the objectives of open-label, long-term extension studies; Describe the role and design of delayed-start studies and single-arm extension studies in the evaluation of efficacy and safety; Discuss ethical considerations when designing and conducting open-label, long-term extension studies.

Chair

Lisa A Kammerman, PhD, MS

Speaker

Delayed-Start Study Design and Analyses for Demonstrating Disease Modification
Scott Andersen, MS

Bioethics of Open-Label Extension Studies
Robert M Nelson

When, if Ever, Open-Label Extension Studies Are Needed and Appropriate (and What Are the Alternatives)?
Jesse Aaron Berlin, DrSc


Chair
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →

Speakers
SA

Scott Andersen

Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored... Read More →
avatar for Jesse Berlin

Jesse Berlin

Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored... Read More →
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum