2. Disclosures
• Grant Funding
• NIH – NINDS
• NIH – NIDCD
• AHRQ
• Editorial
• Methodology statistics reviews for Academic Emergency
Medicine Journal
• Expert Witness
• Medical liability consulting
• Financial
• No companies or patents
• Diversified index funds only
• Sports
• Ohio State Fan
3. Outline
• Part 1: Neurological Emergencies Treatment Trials
• Pre-history
• The launch
• The current trials
• Why I do this
• Part 2: Clinical Trials Methodology Course
• Pre-history
• The launch
• The current model
• Why I do this
• Part 3: DIZTINCT
4. Part 1: Neurological Emergencies Treatment Trials
A long time ago (1990) in a galaxy (Cincinnati) far,
far away…
5. EPISODE IV
A New Hope
Stroke physicians have been stymied
for decades without any acute
treatments to improve outcomes by
reducing the damage from stroke.
They have looked to their
colleagues, the cardiologists for
help, but have met many
roadblocks.
9. Randomized Controlled Trials
•Not easy
•Barriers to entry
•Site principal investigator “props”
•Not enough being done
•Best way to get definitive answers
10. NINDS Clinical Trials
Methodology Course
•Not easy
•Barriers to entry
•Small clinical trials are the hardest
•Junior / new investigators under-
resourced
•Not enough being done
11. 4/29/2016 R25 NS088248 11
April – July
August 7-11 Ann Arbor
August - October
MarchInstruments / Pre-Review
Webinars
Small Group Meetings
Travel / Logistics
Didactics / Workshops /Small
Groups MANDATORY
Small Groups / Mock Study
Sections
PROTOCOLDEVELOPMENTPROPOSALDEVELOPMENT