Think

Tank

Think Tank

CTTI Antibacterial Drug Development:
Statistical Issues Think Tank Meeting

August 20, 2012
Bethesda Hyatt Regency, Bethesda, MD

Project Category: Program DesignProject: ABDD

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.
CLICK HERE to view a blog post resulting from this meeting.
CLICK HERE to view the peer-reviewed publication resulting from this meeting.

 

Meeting Background

On Aug 5, the Journal of Pharmaceutical Statistics published an article by Gamalo et al. that describes a Bayesian approach for the design and analysis of active comparator trials used in the development and market approval of antibacterial drugs. This work was presented in part at the Clinical Trials Transformation Initiative (CTTI) Antibacterial Drug Development: Statistical Issues Think Tank Meeting held on August 20, 2012 in Bethesda, MD.

“The CTTI Statistics Think Tank, a collaborative initiative with the FDA/CDER Anti-Bacterial Drug Development Task Force, was held in August, 2012 and provided an excellent opportunity for leading statisticians from academia, government, and industry to discuss innovative approaches for accelerating the development of new antibiotics. This article presents a comprehensive Bayesian approach to non-inferiority trials and represents but one of several approaches that were discussed at the Statistics Think Tank meeting. We look forward to additional research being published from the ideas generated at that meeting.” said Lisa LaVange Director of Biostatistics, Food and Drug Administration.

The Bayesian approach may allow for use of information from sources that include observational studies and early phase trials on the effect of the active comparator for study design. This approach may aid in reducing large sample size requirements and decrease study durations for antibacterial agents that enter late-stage clinical development. More information on the article is available HERE.

 

Meeting Presentation

CTTI Statistics Think Tank for Anti-Bacterial Drug Development by Lisa LaVange

 


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