Resources for Researchers
Clinical Evaluation—Therapeutics
Trials and NDA (New Drug Application)-Enabling Activities
Develop assays
Scale up for manufacturing
Evaluate reproductive toxicity
Conduct drug combination studies
Evaluate chronic toxicity
Phase 1 trial (Small human trial to evaluate safety)
Phase 2 trial (Larger human trial to evaluate safety and efficacy)
Phase 3 trial (“Definitive” assessment of safety and efficacy in a large population)
Phase 4 trial (Determine safety over time; evaluate other uses)
Support for international clinical studies
Support for Clinical Programs (information only)
DMID Clinical Research Policies and Procedures