NOVEMBER 19, 2014
CTTI Project: Unmet Need
Meeting Objectives
- To provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
- To discuss ongoing challenges in the development and adoption of innovative methods
- To generate strategies to propel antibacterial drug development forward.
Meeting Location:
Bethesda North Marriott Hotel & Conference Center, Bethesda, MD
Meeting Presentations:
Session 1: Current status of drug development and ongoing challenges
- Introduction to CTTI's Clinical Trials Transformation Initiative: Antibacterial Drug Development Project by Lisa M. LaVange
- Summary of Regulatory Standards and Guidances by Joseph Toerner
- Summary of unmet need guidance and statistical challenges by Daniel B. Rubin
- Application of Pharmacokinetics/Pharmacodynamics in New Anti-Infective Drug Development: Current Challenges and Future Perspectivesby Seong Jang
- Statistical Considerations for Antibiotic Drug Development by Aaron Dane
Session 2: Current research and additional opportunities for the future
- Discordant MIC Analysis: Testing for Superiority within a Non-inferiority Trial by Dean Follmann, Erica BriDain, and John Powers
- Hierarchical nested trial design (HNTD) for new antibacterial drugs in patients with emerging bacterial resistance by Thamban Valappil and Mohammad Huque
- Response Adjusted for Duration of Antibiotic Risk (RADAR) by Scott Evans
- Some Proposals in the Analysis of Antibacterial Drug Trials by Margaret Gamalo-Siebers and Ram C. Tiwari
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.