Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Regulatory Submissions + Approvals, Safety
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Overview
Increasing bacterial resistance coupled with decreasing research on new antibacterial drugs is creating a crisis that could disproportionately impact our most vulnerable populations, including children and the seriously ill.
CTTI has created approaches for streamlining antibacterial drug development that will help you design clinical trials that better assess the efficacy and safety of new antibacterial drugs and inform clinical trial planning, recruitment, enrollment, and feasibility. Use CTTI’s recommendations and resources to help combat this complex public health concern.
Projects
ABDD HABP/VABP STUDIES
Learn about CTTI’s prospective, multi-center, observational study of the risk factors for HABP/VABP.
ABDD PEDS TRIALS
Design pediatric antibacterial trials that ensure adequate enrollment, decrease the burden on sites and families, and increase engagement with healthcare providers.
ABDD STREAMLINING HABP/VABP TRIALS
Streamline protocol elements and data collection in HABP/VABP trials to increase enrollment, reduce trial complexity, and optimize operational efficiency.
ABDD UNMET NEED
Read about CTTI’s research findings on patient and physician perspectives and considerations as it relates to using antibacterial drugs developed through streamlined development processes.
Resources
Press Releases
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...
Safety | Press Releases
Children Underrepresented in Drug Studies
CTTI Project: ABDD Peds Trials The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis...
Safety | Poster Presentations
Streamlining Antibacterial Drug Development Programs To Address Unmet Medical Need: Patient And Provider Attitudes On A Modified Benefit-Risk Calculus
American Thoracic Society International Conference 2016 CTTI Project: Unmet Need Download Presentation (785.09 KB)
Poster Presentations
A Collaboration to Facilitate the Development of Antibacterial Agents for Unment Need: Streamlining Clinical Trial Protocols
DIA's 50th Annual Meeting CTTI Project: Streamlining HABP/VABP Trials
Expert Meetings
Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials
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:...
Safety | Expert Meetings
The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward
Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches Identify focus group themes and discuss topics which should be further explored or where draft recommendations...
Safety | Expert Meetings
Statistical Issues Think Tank II
To provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs To discuss ongoing challenges in the development and adoption of innovative...
Expert Meetings
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...
Expert Meetings
Antibacterial Drug Development: Developing a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
The goal of this meeting is to seek solutions for challenges in study design and conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) studies by applying the Quality by Design...
Safety | Expert Meetings
CTTI Antibacterial Drug Development: Statistical Issues Think Tank Meeting
A CTTI-hosted Statistical Issues Think Tank Meeting was convened to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful...
Expert Meetings
Antibacterial Drug Development Working Group Webinar
The Clinical Trials Transformation Initiative hosted an Antibacterial Drug Development Program Working Group Webinar on Aug 29, 2013 to provide an update on the program, and to make further progress...
Safety | Expert Meetings
Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator Associated Bacterial Pneumonia
With rising antibiotic resistance becoming an issue of global concern, the Clinical Trials Transformation Initiative (CTTI) convened a 2-day Antibacterial Drug Development Workshop on October 11-12, 2012 in Crystal City,...
Webinars
Antibacterial Drug Development in a Time of Great Need: Global Expert Panel
On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement.
Safety | CTTI News
Recent CTTI Publication Investigates HABP/VABP Risk and Antibiotic Trial Eligibility for Hospitalized Patients in Europe
A new CTTI publication investigates the prospective identification of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) risk factors and antibiotic trial eligibility among hospitalized, critically ill patients at seven European hospitals.
Publications
PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts
PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts
Case Studies
DCRI’s PTN Builds Efficiencies to Improve the Enrollment, Design, and Conduct of its Studies
DCRI’s PTN Builds Efficiencies to Improve the Enrollment, Design, and Conduct of its Studies
Recommendations
Recommendations for Streamlining Protocol Elements for HABP/VABP Trials
Recommendations for Streamlining Protocol Elements for Hospital-Acquired Bacterial Pneumonia (HABP/VABP)/Ventilator Associated Bacterial Pneumonia (VABP) Trials
Recommendations
Recommendations for Optimizing Efficiency for Data Collection in HABP/VABP Trials
Recommendations Optimizing Efficiency for Data Collection in HABP/VABP Trials
Recommendations
Recommendations for Improving Pediatric Trials in Antibacterial Drug Development
Recommendations for Improving Pediatric Trials in Antibacterial Drug Development
Regulatory Submissions + Approvals | CTTI News
CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP
Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard...