Scientific Symposia Series
Functional MRI in Clinical Trials: State of the Science and Future Directions
12/6/2015 - 12/8/2015
Co-chairs:
Owen Carmichael, Ph.D.
Pennington Biomedical Research Center
Louisiana State University
David Scott, Ph.D.
Bioclinica
Newark, California
Program Description:
Background
Functional magnetic resonance imaging (fMRI) is a promising technology for evaluating
the mechanism of action of a wide variety of novel treatments that act on the brain. Functional
MRI is non-invasive, well tolerated, and sensitive to treatment-related changes in
brain activity that may be too subtle to detect using traditional behavioral testing. However,
there is a large space of fMRI design choices, including sequence parameters, stimulus
presentation paradigms, and post-processing computations. There is little clear guidance
about optimal design settings, and little agreement on how to standardize methods
across laboratories. As a result, fMRI findings in clinical trials may fail to generalize
well across sites and studies, and fMRI has struggled to gain widespread acceptance
as a valid outcome measure.
Objectives
- To review the biological basis for the fMRI signal and the current state of the art in fMRI methodology for identifying treatment effects.
- To understand major factors in the fMRI design space and the effects these factors have on study findings.
- To develop a roadmap for standardization of fMRI methodology
Proposed Meeting Agenda
Sunday, December 6, 2015
6:00 PM |
Tour of Pennington Biomedical Research Center |
6:30 PM |
Welcome Reception and Dinner |
Monday, December 7, 2015
8:30 - 9:00 AM |
Welcome and Opening Remarks |
9:00 - 11:30 AM |
Session 1: Biological Basis of Functional MRI Measurements-What Can fMRI Tell Us? |
11:30 - 12:30 |
Lunch |
12:30 - 3:00 PM |
Session 2: The fMRI Design Space: Imaging, Stimuli, and Analysis |
3:00 - 3:30 PM |
Break |
3:30 - 5:30 PM |
Session 3: fMRI in Clinical Trials: Case Studies |
5:30 - 7:00 PM |
Hospitality Suite |
7:00 - 9:00 PM |
Dinner |
Tuesday, December 8, 2015
8:30-10:30 AM |
Session 4: Ways Forward: Standardizing fMRI Methods and Addressing Regulatory Issues |
10:30-11:00 AM |
Break |
11:00 - 12:00 |
Roundtable Discussion and Generation of Consensus Recommendations For Further Development of fMRI Methods |
12:00 - 1:00 PM |
Lunch |