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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Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials

NOVEMBER 12, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek practical solutions to streamline the operational processes and build efficiencies for data collection in HABP/VABP trials.

Meeting Location:

Arlington, Virginia

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  • Introduction by Pamela Tenaerts

Session 1: Challenges in data collection for HABP/VABP trials

Session 1 Goal: Understanding the issues surrounding data collection in HABP/VABP trials

Session 1 Focus: Why reducing excessive non-critical data collection in HABP/VABP trials would improve data quality, and benefit investigators, sponsors, reviewers, and patients

Session 2: Regulatory requirements for AE data collection in registration trials

Session 2 Goal: Discuss different regulatory requirements and the challenges of meeting these requirements for data collection for HABP/VABP registration trials that are globally conducted, and evaluate whether future work is needed to harmonize approach to AE collection

Session 2 Focus: AE collection and adjudication of relatedness and seriousness; Reporting of SAE’s and SUSARS and evaluation

Session 3: Strategies to simplify data collection using a QbD approach

Session 3 Goal: To simplify the recording, monitoring, and review to make HABP/VABP trials more feasible and economical

Session 3 Focus: Reduction in the amount of data collected by identifying data that are critical to quality and those that may be essential to determine the benefit/risk of the treatment for registration, and those may be less informative

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.