ABDD Peds Trials

Clinical Trials Transformation Initiative Releases New Recommendations to Improve Studies of Antibacterial Drugs for Children

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CTTI Project: ABDD Peds Trial

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. CTTI’s new recommendations for making pediatric antibacterial trials more successful. These practical, evidence-based strategies can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials or pediatric trials in other therapeutic areas.

PDF icon Download Press Release (213.88 KB)

Improving Pediatric Trials in Antibacterial Drug Development | No Sick Child Left Behind

APRIL 05, 2016

CTTI Project: ABDD Peds Trials

Meeting Objectives

  • Present findings
  • Identify remaining gaps that may require further exploration
  • Present and obtain feedback on draft considerations to improve the successful conduct and execution of pediatric antibacterial drug trials
  • Develop initial consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs

Meeting Location:

Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations

  1. CTTI History and Methodology: ABDD Program History by Jamie Roberts
  2. Pediatric Product Development in the 21st Century by Lynne Yao, M.D.
  3. Public-Private Partnerships to Support Pediatric Trials by Ed Connor, MD MBE
  4. Opportunities: Pediatric Trials Network by P. Brian Smith MD MPH MHS
  5. Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov by Joshua Thaden, MD, PhD
  6. Quantifying BPCA and PREA Submissions – Pediatric Labeling for Antibacterial and Antifungal Drugs by John Farley, MD MPH
  7. PENTA-ID by Mike Sharland
  8. Parental Decision Making About Enrolling Children in Clinical Trials: An In-depth Interview Study by Diane Bloom, MPH, Ph.D.
  9. Investigator Perspectives by Amy Corneli, PhD, MPH
  10. Findings: Perspectives from Community Providers by Rachel G. Greenberg, MD
  11. Industry Perspectives by Gary Noel
  12. Communicating with Parents: Approaches to Informed Consent by Breck Gamel
  13. Addressing the Challenges in Neonatal Infection Studies by P. Brian Smith MD MPH MHS
  14. Improving Clinical Trial Design: Meeting the Needs of Investigators by John Bradley, MD
  15. Breakout Report Outs

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trial Project

CTTI Project: ABDD Peds Trials

CTTI has released new recommendations to improve the quality and efficiency of research studies used to develop antibacterial drugs for children. In addition, many of the suggested strategies and practices could be applied to streamline clinical trials of other types of drugs and medical devices for children.

These recommendations resulted from a collaborative effort among research sponsors, parents, investigators, clinicians, and regulators from the US and the EMA (European Medicines Agency), who provided practical suggestions for the timing of pediatric trials, streamlining trial design, facilitating informed consent, and fostering global and community partnerships to conduct trials that can improve children’s health.

Click here to view the press release that accompanied the release of these recommendations.

 

PDF icon Download Slides (653.36 KB)

Webinar Presenters:

  • Sumathi Nambiar, Food and Drug Administration
  • John Bradley, University of California, San Diego
  • Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

Webinar Objective:

The webinar included practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

  • Importance of engaging with regulators early and throughout medical product development
  • Methods of streamlining trial design to decrease burden on sites and families
  • Special considerations for conducting trials with neonates
  • Approaches for improving the informed consent process
  • Ways to increase engagement with healthcare providers

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

Webinar Resources

During the Q&A, Sumathi Nambiar referenced the FDA Workshop on Anti-Infective Drug Development in Neonates.

CTTI Study Shows More Efforts Are Needed to Stimulate Pediatric Antibacterial and Antifungal Drug Trials

Posted on by Lorri Bingham

In an article recently published in Pediatrics, CTTI researchers assess the impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial and antifungal drug trials.

The study, which evaluated pediatric trials conducted between 2007 and 2017, found that nearly two-thirds of pediatric antibacterial and antifungal drug trials were conducted under BPCA or PREA. These trials were more likely to collect pharmacokinetic data and report results than non-BPCA/PREA trials.

However, the overall number of pediatric antibacterial and antifungal drug trials was low, representing less than 1 percent of pediatric trials overall. These trials also rarely enrolled infants up to 30 days old.

The findings show that, while federal legislation is likely having an impact on pediatric antibacterial and antifungal drug trials, more efforts are needed to stimulate these trials and improve the reporting of results.

This study was conducted as part of CTTI’s ABDD Peds Trials Project, which focuses on creating efficient, evidence-based processes to accelerate the development of safe and effective pediatric antibacterial drugs.