Meeting Objectives

• Present findings
• Identify remaining gaps that may require further exploration
• Present and obtain feedback on draft considerations to improve the successful conduct and execution of pediatric antibacterial drug trials
• Develop initial consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs

Meeting Location:

Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations

1. CTTI History and Methodology: ABDD Program History by Jamie Roberts
2. Pediatric Product Development in the 21st Century by Lynne Yao, M.D.
3. Public-Private Partnerships to Support Pediatric Trials by Ed Connor, MD MBE
4. Opportunities: Pediatric Trials Network by P. Brian Smith MD MPH MHS
5. Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov by Joshua Thaden, MD, PhD
6. Quantifying BPCA and PREA Submissions – Pediatric Labeling for Antibacterial and Antifungal Drugs by John Farley, MD MPH
7. PENTA-ID by Mike Sharland
8. Parental Decision Making About Enrolling Children in Clinical Trials: An In-depth Interview Study by Diane Bloom, MPH, Ph.D.
9. Investigator Perspectives by Amy Corneli, PhD, MPH
10. Findings: Perspectives from Community Providers by Rachel G. Greenberg, MD
11. Industry Perspectives by Gary Noel
12. Communicating with Parents: Approaches to Informed Consent by Breck Gamel
13. Addressing the Challenges in Neonatal Infection Studies by P. Brian Smith MD MPH MHS
14. Improving Clinical Trial Design: Meeting the Needs of Investigators by John Bradley, MD
15. Breakout Report Outs