Advances in clinical trial design over the past decade have offered new and accelerated pathways for drug development. Despite this, the development of novel antibacterial therapies is lagging due to scientific and economic challenges. To address this critical unmet need, CTTI has hosted meetings to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.

On November 19, 2014, CTTI, in collaboration the FDA’s Antibacterial Statistics Working Group, convened the second meeting of statistical and medical experts in the area of antibacterial drug development. The goals of this meeting were to:

• Provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
• Discuss ongoing challenges in the development and adoption of innovative methods
• Generate strategies to propel antibacterial drug development forward

We are pleased to share an Executive Summary of this meeting, in addition to the presentations and agenda. Click here to view all meeting materials.

*This meeting is part of CTTI’s Unmet Need in Antibiotic Development Project.