Research Methodology, Education, and History, Academic, Futures In Neurological Research
Laurie Gutmann MD, FAAN
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.
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.
Medical Knowledge, Practice-based Learning and Improvement
Program Speakers - Tentative
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
William Joseph Meurer MD
8:20 AM - 9:00 AM
Building a Trial – An Interactive Exercise
Christopher Coffey PhD, Robin A. Conwit MD, FAAN, Laurie Gutmann MD, FAAN, William Joseph Meurer MD
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 personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Expansion Therapeutics. Dr. Gutmann has received research support from Expansion Therapeutics, and Alexion.
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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