| Sunrise Course:
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| Trials & Tribulations: Multicenter Trial Headaches
& Their Cures |
|
Organizers: Nicola de Stefano, M.D.,
Ph.D., and Jeffrey Joseph Neil, M.D.,
Ph.D. |
| |
| Skill Level:
Basic - Intermediate |
| Tuesday - Friday, 4-7 May
2010 |
| 07:00 - 08:00 |
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OVERVIEW |
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This four-hour course is aimed at
providing a better understanding of the underlying principles behind
and issues with running a multicenter imaging trial. Topics will
include site certification, trial execution, liability and safety
monitoring, detecting relative changes in the brain, and surrogate
markers. Speakers will consist of Ph.D. researchers and clinician
scientists with extensive clinical trial experience. |
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EDUCATIONAL OBJECTIVES |
Upon completion of this course
participants should be able to:
- Describe multiple methods for
setting up and maintaining site quality and certification for
multicenter imaging trials;
- Explain the issues related to
performing research involving INDs or IDEs;
- Evaluate the sensitivity,
specificity and reliability of current imaging methods to detect
relevant quantitative changes within the brain; and
- Describe the underlying
principles for adopting and evaluating potential surrogate
imaging markers for assessment of drug efficacy.
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| Tuesday
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Basic
Prerequisites for Multicenter/Multiscanner Trials
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| 07:00 |
QA & Site Certification
|
Robert C.
McKinstry, M.D., Ph.D. |
| 07:30 |
Trial Execution: Methods to
Drive Standardization |
Matt A.
Bernstein, Ph.D. |
| 08:00 |
Adjournment |
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| Wednesday
|
Trying Drugs & Devices:
Safety & Liability |
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| 07:00 |
Multicenter Drug Trials
|
A. Gregory
Sorensen, M.D. |
| 07:30 |
Trials Using Devices
|
Christine H.
Lorenz, Ph.D. |
| 08:00 |
Adjournment |
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| Thursday
|
Detecting Relevant
Changes in The Brain |
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| 07:00 |
Sensitivity & Specificity
in Real Patients
- not available |
Frederik Barkhof,
M.D., Ph.D. |
| 07:30 |
Data Analysis: Potential
Pitfalls & Sources of Error |
Mara Cercignani,
Ph.D. |
| 08:00 |
Adjournment |
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| Friday |
Surrogate Markers
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| 07:00 |
MR Metrics as Biomarkers for
Pharma Studies |
Paul M.
Matthews, M.D., Ph.D. |
| 07:30 |
The Lesson of MS: Is MRI
Useful as Surrogate Marker? |
Maria Pia
Sormani, Ph.D. |
| 08:00 |
Adjournment |
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