Table 4.

Moody Project Symposium Discussion Topics and Questions

Topic	Questions
Model and therapy selection	Models
	1. Should multiple models be used for therapy testing? If so, how many and which ones?
	2. Should models be standardized across sites?
	3. Injury severity? Mild, moderate, severe? Repetitive mild?
	4. Should studies include both genders?
	5. Should anesthetics be constant across sites?
	6. Should secondary (post-traumatic) insults (e.g., hypotension, hypoxemia) be included?
	Therapies
	1. Therapy selection? FDA approved? Human use approval? BBB permeability?
	2. Should PD/PK be established prior to efficacy testing?
	3. Time/route of administration? How many doses?
	4. Should the same doses and routes and times of administration be used in all models?
Outcomes	1. Which ones?
	2. How should outcomes be weighted in “efficacy score”?
	3. Should outcomes be standardized across sites?
	4. At what time after injury should outcomes be assessed?
	5. Long-term (> 21 days) outcomes?
	6. Serum biomarkers? Which ones? Should biomarker data be included in the efficacy score?
	7. Should mechanistic outcomes be included to confirm/refute theoretical mechanisms(s) of action?
	8. Should outcomes be standardized and/or normalized across sites?
	9. Which outcomes must be positive to recommend a therapy for clinical testing?
Data collection, analysis, sharing and intersite communication	1. Should common data elements be “common” across all sites?
	2. How should the outcome data be analyzed?
	3. Should the data be shared outside of the consortium?
	4. Should data be analyzed by each site or at a data analysis core?
	5. Should studies include Go/No-Go preliminary analyses or short-term outcome screening?
	6. Should studies include an interim analysis?
	7. Should data be shared among sites while collection is in progress?
	8. What types of intersite communication should be permitted/encouraged?

BBB, blood–brain barrier; FDA, Food and Drug Administration; PD/PK, pharmacodynamics /pharmacokinetics.