Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of community-acquired pneumonia, effect of antimicrobial treatment for community-acquired pneumonia, endpoints for trials of community-acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion.
The FR Notice, Agenda, and Transcripts from the workshop are available (see links below).
- Federal Register Notice [HTML] [PDF]
- Agenda [PDF]
- January 17th Transcript [PDF]
- January 18th Transcript [PDF]