Sunrise Course:
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

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.
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.

Tuesday Basic Prerequisites for Multicenter/Multiscanner Trials
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  
Wednesday Trying Drugs & Devices: Safety & Liability  
07:00 Multicenter Drug Trials A. Gregory Sorensen, M.D.
07:30 Trials Using Devices Christine H. Lorenz, Ph.D.
08:00 Adjournment  
Thursday Detecting Relevant Changes in The Brain  
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  
Friday Surrogate Markers  
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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