C39 - How to Design Meaningful Clinical Trials

Event Time:	Sunday May 5, 2019 7:00 am to 9:00 am
Topic(s):	Research Methodology, Education, and History, Academic, Futures In Neurological Research
Director(s):	Laurie Gutmann MD, FAAN
Description:	Clinical research design methodology is important not only to the development of a clinical trial but also in understanding the results of a reported clinical trial. Major flaws in trial design include: designing a phase 2 trial that does not lead to a stronger phase 3 trial, choosing outcome or endpoint measures that either do not answer the question being raised by the trial or do not inform the next step in the study, or designing the phase 2 trial as an underpowered phase 3 trial. This program will review trial design for early phase trials and review examples motivated from experience gained as part of the NINDS-funded clinical trials methods training course that aim to avoid these pitfalls. A panel will then discuss how to design a trial based on examples and clinical trial questions received from the audience.
Completion Message:	Participants should have a better understanding of how to design a clinical trial, how to choose a appropriate design and interpret validity of findings from a clinical trial, as well as the importance of endpoint measures.
CME Credits:	2
Core Competencies:	Medical Knowledge, Practice-Based Learning and Improvement

Program Speakers - Tentative
Start/End Time	Title	Faculty
7:00 AM - 7:40 AM	Introduction to Meaningful Clinical Trial Design: Pitfalls and Pearls	Christopher Coffey PhD
7:40 AM - 8:20 AM	Endpoint Selection and Outcome Measures	Faculty
8:20 AM - 9:00 AM	Building a Trial – An Interactive Exercise	Christopher Coffey PhD, Robin A. Conwit MD, FAAN, Laurie Gutmann MD, FAAN, Roger Lewis MD, PhD, William Joseph Meurer MD

Disclosures
Speaker	Disclosure
Christopher Coffey, PhD	Dr. Coffey has nothing to disclose.
Robin A. Conwit, MD, FAAN	Dr. Conwit has nothing to disclose.
Laurie Gutmann, MD, FAAN	Dr. Gutmann has received research support from Alexion Pharmaceuticals.
Roger Lewis, MD, PhD	Dr. Lewis has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Berry Consultants, LLC.
William Joseph Meurer, MD	Dr. Meurer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with various law firms, regarding medicolegal cases. Dr. Meurer has received personal compensation in an editorial capacity for Trials and Academic Emergency Medicine Journal.

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C39 - How to Design Meaningful Clinical Trials

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