Antibacterial Drug Development
CTTI Presents on Patient & Provider Attitudes on Streamlined Antibacterial Drug Development at ATS 2016
Resistance to available antibiotics is increasing. Despite the critical need for novel antibacterial therapies, their development is lagging. At the 2016 American Thoracic Society (ATS) International Conference, Deborah Collyar, a project team member for CTTI’s Unmet Need in Antibiotic Development Project, will present results from interviews and focus groups on patient and provider attitudes toward using streamlined approaches for antibacterial drug development. These findings will be used to develop recommendations to improve the uptake and appropriate use of antibacterial therapies that are developed through streamlined approaches to address the critical unmet need for novel antibacterial therapies.
If you are attending the conference, please stop by to learn more:
ATS 2016 International Conference Conference
Location: San Francisco, California
Poster: Streamlining Antibacterial Drug Development Programs to Address Unmet Medical Need: Patient and Provider Attitudes on a Modified Benefit-Risk Calculus
Date & Time: Sunday, May 15, 2016, from 9:00 AM-4:15 PM PT
Presenter: Deborah Collyar
CTTI Reveals Findings from Pediatric Antibiotic Trials Project at PAS 2016
Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.
After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.
Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine
Materials from CTTI’s Unmet Need in Antibiotic Development Meeting Now Available
On March 1, 2016, CTTI hosted an expert meeting entitled, 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. We are pleased to now share the meeting materials online, including the presentations, agenda, and attendee list.
This meeting was associated with the Unmet Need in Antibiotic Development Project. A variety of stakeholders attended, including academia, clinical experts, patient advocates, regulators, pharmaceutical companies, and others involved in the clinical research enterprise. The meeting objectives were to:
- 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 could be made
- Obtain feedback to improve labeling, risk communication, public understanding and stewardship
Now Available: Poster on Cost Drivers of HABP/VABP Phase 3 Clinical Trials
On October 9, 2015, results from CTTI’s Streamlining HABP/VABP Trials Project were presented in the poster session, Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials, at ID Week 2015 in San Diego, CA. This poster explores the drivers of HABP/VABP direct and indirect clinical trial costs and identifies opportunities to lower these costs.
CTTI Presents on Cost Drivers of HABP/VABP Phase Three Clinical Trials at ICAAC/ICC 2015
We are pleased to announce that CTTI’s HABP/VABP Trials Project will be presenting a poster at ICAAC/ICC 2015. In September, the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) will host this conference, intended for clinical microbiologists, infectious disease physicians, researchers, and pharmacists.
Session Details:
- Title: Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials
- Date: September 18, 2015
- Time: 12:00 – 2:00 PM
- Presenter: Stella Stergiopoulos
We look forward to connecting with colleagues at this event.
Executive Summary Available for CTTI’s Statistical Issues in Antibiotic Development Think Tank II
Advances in clinical trial design over the past decade have offered new and accelerated pathways for drug development. Despite this, the development of novel antibacterial therapies is lagging due to scientific and economic challenges. To address this critical unmet need, CTTI has hosted meetings to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.
On November 19, 2014, CTTI, in collaboration the FDA’s Antibacterial Statistics Working Group, convened the second meeting of statistical and medical experts in the area of antibacterial drug development. The goals of this meeting were to:
- Provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
- Discuss ongoing challenges in the development and adoption of innovative methods
- Generate strategies to propel antibacterial drug development forward
We are pleased to share an Executive Summary of this meeting, in addition to the presentations and agenda. Click here to view all meeting materials.
*This meeting is part of CTTI’s Unmet Need in Antibiotic Development Project.
CTTI Heads to ACRP 2015 to Discuss Central IRBs, Accelerating Antibacterial Drug Development, and More
On April 25-28, 2015, the single largest gathering of clinical research professionals in North America, ACRP 2015, will take place in Salt Lake City, Utah. CTTI will be presenting at several events throughout the conference to share our evidence-driven, actionable solutions to the barriers of clinical trial efficiency and quality. We look forward to connecting with our colleagues at the following events:
Presentation: Streamlining protocols for operational efficiency: HABP/VABP trials for unmet need (Poster)
Date: April 25, 2015 from 1:30 – 2:30 PM
Presenter: Sara Calvert (CTTI)
Presentation: Mobile Technology and Clinical Research (Panel)
Date: April 26, 2015 from 8:30 – 10:30 AM
Presenters: Matt Harker (CTTI), Corey Bridges (LifeMap Solutions), Solomon Abiola (University of Rochester)
Presentation: CTTI use of central IRBs for multicenter clinical trials (Concurrent Session)
Date: April 27, 2015 from 8:30 – 9:30 AM
Presenters: Sara Calvert (CTTI), Cynthia Hahn (Feinstein Institute for Medical Research), Soo Bang (Celgene)
Presentation: Strategies to Increase the Efficiency of Good Clinical Practice (GCP) Training (Concurrent Session)
Date: April 27, 2015 from 11:00 AM – 12:00 PM
Presenters: Jonathan Seltzer (ACI Clinical)
For a complete list of upcoming events for CTTI, click https://ctti-clinicaltrials.org/upcoming-events/here.