Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Presentations
- Workshop Welcome (PDF - 47KB) - David Gilbert, MD
- Adult CAP of modest severity not requiring hospitalization (PDF - 140KB) - David Gilbert, MD
- Clinical endpoints of therapy for mild-moderate CAP (PDF - 3MB) - David Gilbert, MD
- Overview of recent CAP trials: Non-inferiority trial design and endpoints (PDF - 228KB) - Karen Higgins, Sc.D.
- Pre-marketing assessment of drug safety in CAP (PDF - 62KB) - Tatiana Oussova, MD, MPH
- Treatment effect of antibacterial drugs in community-acquired pheumonia: A historical and regulatory perspective (PDF - 672KB) - Mary Singer, MD, PhD
- FDA experience and perspective on non-inferiority trials (PDF - 241KB) - Robert Temple, MD