Regulatory Submissions + Approvals

Improving Pediatric Trials in Antibacterial Drug Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

View Expert Meeting MaterialsOn April 5, 2016, CTTI’s Pediatric Antibiotic Trials Project hosted a multi-stakeholder expert meeting to develop consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs. Findings from the project’s surveys and interviews were presented, and stakeholders from across the clinical trial enterprise provided input on draft considerations for improving pediatric antibacterial drug trials.

Areas of focus at the expert meeting included challenges in designing and conducting pediatric trials (including neonatal studies), pediatric labeling, and informed consent. Potential strategies discussed to address these challenges included developing pan-global networks to conduct pediatric trials using master protocols, achieving alignment between global regulatory agencies, improving awareness of opportunities for industry to communicate with the FDA when designing Pediatric Study Plans, and improving communication in the consent process.

We now invite you to view the materials from this meeting. The multi-stakeholder feedback from the meeting, along with evidence gathered through the CTTI project, is being used to inform the development of recommendations to help achieve higher quality, more efficient pediatric trials for antibacterial drugs. CTTI’s official recommendations are expected to be released in 2017.

CLICK HERE to access the meeting summary, slides, agenda, and other materials

This project is part of CTTI’s Antibacterial Drug Development Program.

Webinar Recording Available: Global Expert Panel on Antibacterial Drug Development

CTTI News | September 15, 2016

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

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. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

Learn more about CTTI’s Streamlining HABP/VABP Trials Project and Antibacterial Drug Development Program.

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Unmet Need in Antibiotic Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 1, 2016, CTTI hosted a multi-stakeholder expert meeting for its Unmet Need in Antibiotic Development Project. This project is investigating perceptions of antibacterial drugs developed using accelerated pathways. Non-traditional development pathways can expedite the availability of much-needed new antibacterial therapies, but there is a tradeoff in risk and uncertainty.

At the expert meeting, results were presented from focus groups and interviews conducted to elicit opinions from patients, healthy persons, caregivers, and physicians on the use of antibacterial drugs developed using streamlined approaches. Meeting attendees, which included representatives from academia and pharmaceutical companies, patient advocates, regulators, and other stakeholders, discussed ways to improve labeling, risk communication, and public understanding in the context of streamlined antibacterial drug development approaches. This input informed interpretation of the findings and project next steps. We are now pleased to share the meeting materials, which may inform others working to address the serious public health issue of antibacterial resistance.

CLICK HERE to access the meeting summary, slides, agenda, and other materials.

This project is part of CTTI’s Antibacterial Drug Development Program.

Upcoming Webinar: Global Expert Panel on Antibacterial Drug Development

Posted on by Lorri Bingham

CTTI invites you to participate in a free, public webinar to learn about collaborative and innovative approaches to address the international public health crisis of antibacterial resistance. A panel of preeminent thought leaders will present these efforts, which appear in a recently published peer-reviewed supplement in the journal Clinical Infectious Diseases (CID).

The webinar will include the presentation of two new sets of CTTI recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

This work is part of CTTI’s Antibacterial Drug Development (ABDD) Program, which includes a portfolio of projects tackling specific issues intended to improve clinical trials evaluating potential new antibacterial drugs.

We encourage you to share this invitation with others who may be interested in learning more about CTTI’s ABDD Program and the HABP/VABP Recommendations.

Webinar Title: Antibacterial Drug Development in a Time of Great Need: Global Expert Panel

Date & Time: Wednesday, August 24, 2016, from 12:00 p.m. – 1:00 p.m. EDT (New York, GMT-04:00)

Speakers:

  • Edward Cox, MD, MPH, U.S. Food and Drug Administration
  • Vance G. Fowler Jr, MD, MHS, Duke University
  • Bruno François, MD, University Hospital of Limoges, France
  • Hasan S. Jafri, MD, MedImmune
  • John H. Powers III, MD, George Washington University School of Medicine
  • John H. Rex, MD, AstraZeneca Pharmaceuticals
  • Pamela Tenaerts, MD, MBA, Clinical Trials Transformation Initiative

Webinar Login: CLICK HERE to enter the meeting.

Meeting Number: 730 531 918

Meeting Password: ctti

After you connect to the website, please follow step-by-step instructions for connecting to the audio.

 

If you prefer to connect to audio only, you can join by phone at:

1-855-244-8681 Call-in toll-free number (US/Canada)  

1-650-479-3207 Call-in toll number (US/Canada)

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

Posted on by Lorri Bingham

Today, CTTI released two new sets of recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). This work is part of CTTI’s antibacterial drug development program, which includes a suite of projects tackling specific issues to improve clinical trials and bolster the pipeline for new antibacterial drugs.

CTTI’s new 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 the adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.

“The CTTI project teams’ work is the type of science that can benefit the overall field of antibacterial drug development by advancing the science of clinical trials for hospital-acquired and ventilator acquired pneumonia,” said Edward M. Cox, M.D., M.P.H., Director of the Office of Antimicrobial Products from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. “We look forward to continued progress of the CTTI effort and the results from additional studies that will evaluate proposed solutions to these challenges.”

CTTI’s latest recommendations appear as part of a peer-reviewed supplement in the journal Clinical Infectious Diseases that features collaborative and innovative approaches by CTTI and others to address this pressing public health concern and speed new treatments to patients.

“This supplement from Clinical Infectious Diseases is really impressive and broad, highlighting many of the problems within antimicrobial resistance, from how to improve the development of new drugs, to engaging with the private sector. I am delighted to see such a prestigious scientific journal engage with this issue in a holistic approach looking at policy as well as scientific actions that need to be taken” said Jim O’Neill, Chair of the AMR Review.

Antibacterial resistance is an international public health crisis, and new treatment options are urgently needed. HABP/VABP occurs in seriously ill patients and is associated with high rates of antibiotic resistance and mortality. Multiple comorbidities, the rapid time course of acute illness, and other factors make conducting clinical trials in this population especially complex. “As someone whose susceptibility to multiple infections and Pneumonias has plagued me for six decades, these recommendations signal a transformational breakthrough,” said Stephen Mikita, patient advocate.

On August 24, CTTI will host a public webinar on this topic: Antibacterial Drug Development in a Time of Great Need: Global Expert Panel.

Materials from CTTI’s Unmet Need in Antibiotic Development Meeting Now Available

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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.

We are pleased to share this poster on our website.

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

Posted on by Hannah Faulkner

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

CTTI Presents on Cost Drivers of HABP/VABP Phase Three Clinical Trials at ICAAC/ICC 2015

Posted on by Lorri Bingham

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.

New Publication Addresses Rising Antibiotic Resistance and Clinical Trial Design

Posted on by Lorri Bingham

On June 23, 2014, an article titled Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance was published online in Statistics in Medicine. This article describes a novel clinical trial model to determine efficacy of antibacterial drugs in trial populations with emerging antibiotic-resistant bacterial infections.

Authors Mohammad Hugue and colleagues cite the CTTI-hosted Statistical Issues Think Tank where they and other experts were able to exchange ideas that in part lead to the development of the model.

For more information on this meeting, including the list of attendees, agenda, presentations, and background summary, CLICK HERE.