Antibacterial Drug Development-Streamlining HABP/VABP Trials

New Results on Cost Drivers in Phase 3 Drug Trials for HABP/VABP

Posted on by Lorri Bingham

Drug-resistant infections are on the rise, and one type of serious infection that can be caused by drug-resistant bacteria is hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Despite the desperate need for effective new therapies for HABP/VABP, clinical trials for this condition are lagging due to difficulties in conducting these trials and low expected return on investment. A new study from CTTI and the Tufts Center for the Study of Drug Development, published in Clinical Infectious Diseases, calculates the cost of phase 3 trials for HABP/VABP and identifies areas of opportunity to lower costs and boost investment in these critically important studies.

“To meet the urgent public health need for new antibacterial drugs, clinical trials must be more efficient, cost-effective and feasibly executed. Our study identified several factors driving clinical trial costs that can be targeted to optimize the development of new treatments,” said Ken Getz, an associate professor and researcher at Tufts University involved in the study.

“Leveraging evidence to direct meaningful changes in clinical trials is what CTTI is all about,” said Pamela Tenaerts, CTTI executive director. “We hope this information will help target efforts to streamline HABP/VABP trials, which will ultimately benefit patients.”

Key findings include:

  • The cost of a phase 3 HABP/VABP clinical trial averages $89.6 million, which is over double the average cost of a phase 3 oncology trial
  • Per patient, phase 3 HABP/VABP clinical trials were $2,300 more expensive than oncology clinical trials and $31,900 more expensive than endocrine trials
  • Screening failure rates and the cost of screening failures were the biggest drivers of cost, suggesting sponsors and research sites should consider ways to increase the number of potentially eligible patients

CTTI released recommendations for streamlining HABP/VABP trials and is testing novel approaches to make these trials more feasible, such as using predictive models to find and consent patients earlier in the disease process.

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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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 Hannah Faulkner

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

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.

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted on by Hannah Faulkner

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted on by Hannah Faulkner

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team