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C148 - Developing the Treatments of Tomorrow II: Clinical Trials in Neurology

Event Time: Tuesday April 25, 2017 3:30 pm to 5:30 pm
Topic(s): Research Methodology, Education, and History
Director(s): Jeffrey Gelfand MD, MAS, FAAN
Description: This program will provide an overview and update of the science of clinical trials for practicing neurologists, researchers, and trainees. Clinical trials are the bedrock of evidence-based neurology and one of the greatest methodological innovations of modern medicine. Academic, industry, and regulatory representatives will provide an overview of clinical trials, discuss approaches to optimize success, review advances in trial design and implementation, and address statistical and regulatory considerations. Faculty will also facilitate a discussion with the attendees. A companion session will address the preclinical drug development pipeline, translation of research breakthroughs to the clinic, and first-in-human studies. This program complements C132: Developing the Treatments of Tomorrow I: Taking Molecules from Lab to Human, but covers independent topics.
Completion Message: Participants should be able to understand differences between early and late stage clinical trials and their role in the drug development pipeline, assess the strengths and weaknesses of various clinical trial designs, use appropriate statistical approaches, and understand regulatory issues.
CME Credits: 2
Core Competencies: Medical Knowledge, Systems-Based Practice

Program Speakers - Tentative

Start/End Time Title Faculty
3:30 PM - 3:40 PM Introduction: Clinical Trials in the Drug Development Pipeline Wendy Galpern MD, PhD, FAAN 
3:40 PM - 4:05 PM Considerations for Early and Late Stage Trials Gilmore O'Neill MD, MB, MRCPI 
4:05 PM - 4:25 PM Statistical Considerations for Designing and Interpreting Clinical Trials Christopher Coffey PhD 
4:25 PM - 4:45 PM Regulatory Considerations for Clinical Trials in Neurology Lei Xu MD 
4:45 PM - 5:05 PM Innovations in Clinical Trial Design and Implementation Jeffrey Gelfand MD, MAS, FAAN 
5:05 PM - 5:30 PM Discussion / Questions and Answers Faculty 


Speaker Disclosure
Christopher Coffey, PhD One-time consultant for Summit Therapeutics.

Wendy R. Galpern, MD, PhD, FAAN Dr. Galpern has received personal compensation for activities with Janssen Research and Development / Johnson and Johnson as an employee.

Jeffrey Marc Gelfand, MD, MAS, FAAN Dr. Gelfand has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with . Dr. Gelfand has received research support from Genentech and MedDay. He has also received personal compensation for medical legal consulting..

Gilmore N. O'Neill, MD, MB, MRCPI Dr. O'Neill has received personal compensation for activites with Biogen as an employee. Dr. O'Neill holds stock and/or stock options in Biogen.

Lei Xu, MD Dr. Xu has nothing to disclose.

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