Apply Filter View All

November ABDD Expert Meeting Materials Now Available

CTTI Project Category: Investigational PlanCTTI hosted a meeting entitled, "Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials" on November 12, 2013 in Crystal City, VA, as part of their Data Collection Workstream of the Streamlining HABP/VABP Trials Project. A variety of stakeholders attended the workshop, including academia, clinical experts, patient advocates, regulators, pharmaceutical companies, and others involved in the clinical research enterprise.

Attendees sought practical solutions to streamline operational processes, and identify efficiencies for data collection in (HABP/VABP) trials to make them more feasible and economical. Issues that lead to excess data collection in these trials were discussed. Data critical to drug safety and efficacy were identified in joint, and breakout sessions using a Quality by Design (QbD) approach in an attempt to simplify the recording, monitoring, and review of these data. This effort will be continued within multi-stakeholder working groups to further develop potential solutions and to propose recommendations for streamlining data collection in HABP/VABP trials.

"Quality by Design techniques applied to HABP/VABP trials can optimize operational efficiency in order to increase the value of data collected while minimizing the burden of unnecessary data collection on patients, investigators and those that oversee the conduct of the trials. This increase in the efficiency of the clinical trial ecosystem will accelerate the development of novel antibacterial drugs to serve this critical unmet medical need. The multi-stakeholder environment offered by CTTI allows us to develop strategies to make data collection more practical while incorporating input from multiple viewpoints and allowing for quick implementation," said Dr Charles Knirsch, MD, MPH, VP Vice President, Clinical Research Head of Specialty Care, Pfizer Inc and a co-team lead for the ABDD Data Collection Workstream.

CLICK HERE to view the agenda, slides and workshop-related materials.