This study will provide a comprehensive program of infrastructure development, methods development, and innovative research to generate real-world evidence addressing critical gaps in the regulation of medical products. We will explore four related issues: Potential for existing medical products to precipitate suicidal ideation and behavior; potential for existing medical products to reduce risk of suicidal behavior; potential for anticipated new medical products to reduce risk of suicidal behavior; and individual variation in liability to both adverse and therapeutic effects.
Effects of Medical Products on Suicidal Ideation and Behavior: Real World Evidence
Investigator: Sterling, Stacy
Funder: U.S. Food and Drug Administration