Antibacterial Drug Development

Clinical Trials Transformation Initiative Releases New Recommendations to Improve Studies of Antibacterial Drugs for Children

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CTTI Project: ABDD Peds Trial

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. CTTI’s new recommendations for making pediatric antibacterial trials more successful. These practical, evidence-based strategies can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials or pediatric trials in other therapeutic areas.

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Clinical Trials Transformation Initiative Releases Recommendations to Enhance the Feasibility of Developing New Antibacterial Drugs

CTTI Project: ABDD Streamlining HABP/VABP

CTTI’s two new sets recommendations outline innovative approaches to designing clinical trials for HABP/VABP, including early enrollment strategies and the streamlined collection of safety data. CTTI convened multi-stakeholder teams to analyze the challenges associated with HABP/VABP trials and develop the proposed solutions. The feasibility of these new approaches will be tested in an upcoming pilot study, the findings of which are expected to help drive adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.

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Understanding Issues in Antibacterial Drug Development Webinar

APRIL 18, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

This webinar provides a background and overview of the issues and many years-long discussions in antibacterial drug development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

Meeting Objectives:

This webinar served to familiarize the diverse group of participating experts with detailed information on this research topic as a preamble to the HABP/VABP pilot study protocol workshop that occurred in Bethesda on April 22 - 23, 2013.

Meeting Location:

Online

All of the attendees of the April 22 - 23, 2013 Expert Meeting where invited to attend this webinar. CLICK HERE for a list of meeting invitees.

Meeting Presentation: