Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach
Antibacterial Drug Development-Peds Trials
Two CTTI Papers Explore Perceptions on Enrolling Children in Clinical Trials
Two papers from CTTI’s Peds Trials work on barriers to enrolling children in clinical trials were recently published in Contemporary Clinical Trials Communications. Despite the fact that pediatric trials are required for new drugs, these trials can be especially difficult to design, enroll, and complete. CTTI’s papers explore the challenges from both the provider and parent perspective and suggest ways to overcome them.
- “Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative” shares findings from an online survey conducted by CTTI of pediatric providers across the U. S. The survey found that lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. The paper notes “understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.”
- “Parents’ perceived obstacles to pediatric clinical trial participation: Findings from the Clinical Trials Transformation Initiative” discusses the results of in-depth interviews with parents who were approached to enroll their children in a clinical trial. The interviews found that establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents’ decisions. The paper recommends solutions related to budget allocations, staffing, and the consent process as ways to make parents’ priorities and considerations a central focus in clinical trials.
Based on feedback from parents, providers, and other stakeholders, CTTI developed actionable recommendations to address the challenges of enrolling children in clinical trials. These recommendations offer practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric trials.
CTTI Shares Challenges and Solutions to Enrolling Participants in Pediatric Trials at AAP 2017
At the upcoming American Academy of Pediatrics National Conference, CTTI will offer insights into some of the biggest challenges currently affecting pediatric clinical trial enrollment and conduct. Through a podium presentation and poster sessions, CTTI will share survey-based findings that shed new light on obstacles affecting pediatric trials and discuss possible solutions that can help streamline these studies and reduce burdens on patients, families, and providers.
Although clinical trials are essential for ensuring access to safe and effective therapies for children, many studies struggle to enroll pediatric participants and families and providers often lack information to help them make the best possible treatment choices. This problem is especially acute for children and infants at risk of harm from bacterial infections, many of which are increasingly resistant to antibiotic treatment. For this reason, maintaining a strong pipeline of safe and effective therapies is an urgent priority.
CTTI’s Peds Trials project, part of the larger Antibacterial Drug Development Program, is actively addressing these gaps and has created evidence-based recommendations designed to improve and streamline pediatric trial development and conduct. We hope you will join us in Chicago this Sept. 16-19 as we share new insights into challenges affecting pediatric trial enrollment, including reasons that parents refuse trials and provider perceptions of obstacles.
Poster & Podium Presentation: Obstacles to Pediatric Clinical Trial Enrollment: Why Parents Refuse; Findings from the Clinical Trials Transformation Initiative
Date & Time: Monday, Sept. 18, 12:35 p.m.–12:50 p.m. (oral presentation)
Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)
Presenter: P. Brian Smith (Duke University)
Poster: Barriers to Pediatric Clinical Trial Enrollment: Findings and Recommendations from the Clinical Trials Transformation Initiative
Date & Time: Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)
Presenter: P. Brian Smith (Duke University)
Webinar Recording Now Available: CTTI Recommendations for Improving Pediatric Antibacterial Drug Trials
Do you struggle with enrolling babies and children in clinical trials? Are you tired of not having the evidence you need to treat kids with serious infections?
A recording is now available of CTTI’s webinar discussing the new CTTI recommendations on improving antibacterial drug trials for children. Experts from FDA, academia, and pharma described the challenges of conducting pediatric antibacterial drug trials, along with practical, evidence-based strategies to improve the quality and efficiency of these trials. These strategies were developed with input from multiple stakeholders and can be used by research sponsors, investigators, and site staff to make pediatric trials more successful.
View the recording to learn ideas on how you can create better clinical trials for children, such as:
- 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
These recommendations are a result of CTTI’s ABDD Peds Trials Project.
To view recordings of other CTTI webinars, click here.
CTTI Releases New Recommendations to Improve Studies of Antibacterial Drugs for Children
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.
“Medically, children are not just little adults, and they need access to treatments that have undergone appropriate evaluation for safety and efficacy in children,” said Daniel Benjamin Jr., MD, PhD, MPH, a pediatric infectious diseases specialist at Duke University. “The CTTI recommendations address many of the common challenges of conducting this research, and if applied widely, can help deliver much-needed information and treatments to benefit our young patients.”
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.
The time from approval of a new antibacterial drug for use in adults to pediatric labeling can be 5 years or longer, potentially delaying appropriate use of medicines for this vulnerable group. Antibacterial resistance is on the rise in children, and the very young can be particularly susceptible to severe illness or death from these pathogens. Despite the great need for more treatment options, many trial sponsors have challenges enrolling pediatric patients in antibacterial drug trials.
“These recommendations encourage consultation with the FDA on pediatric study plans early in drug development and emphasize the potential utility of global study networks and streamlining trials,” said Sumathi Nambiar, MD, MPH, Director of the Division of Anti-Infective Products at the U.S. Food & Drug Administration (FDA). “Our mutual goal is to provide data in the drug labeling that will better inform the safe and effective use of antibacterial drugs in children.”
The CTTI recommendations are meant to help researchers design trials that are less burdensome for families, as well as to support improved practices for approaching parents for consent during the stressful time of a child’s illness. These recommendations are based on research that showed 80% of clinicians surveyed identified parent concerns about their child participating in research to be a barrier for completing research studies with children. This emphasizes the need for better engagement with parents throughout a clinical trial, including during the initial design stage. “This work matters to the lives of families like mine,” said Breck Gamel, a parent participant in the CTTI effort. CTTI studied other clinician concerns as well, which helped to identify educational gaps in pediatric labeling and the need for better engagement with other healthcare providers.
*These recommendations are the result of CTTI’s ABDD Peds Trials Project.
**To read this press release in full, click here.
Webinar February 16: Improving Pediatric Antibacterial Drug Trials
Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. There are now evidence-based, consensus-driven solutions. Are you ready to do better clinical trials for children?
Join us for a special webinar in which CTTI will unveil new recommendations for improving pediatric antibacterial clinical trials:
Title: CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trials Project
Date: February 16, 2016 12:00 – 1:00 PM EST (GMT-05:00)
Webinar Link: http://bit.ly/2kYGm7j
Speakers:
- Sumathi Nambiar, U.S. Food and Drug Administration
- John Bradley, University of California, San Diego
- Gary Noel, Johnson and Johnson Pharmaceutical Research and Development
The webinar will include 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.
This webinar is open to the public. Please feel free to share this invitation with your colleagues.
Parent & Provider Input on Opportunities to Improve Antibacterial Clinical Trials: Findings Presented at Cystic Fibrosis
On October 27, CTTI presented findings from its Pediatric Trials in Antibacterial Drug Development Project at the North American Cystic Fibrosis Conference. Conducting antibacterial trials in pediatric populations has unique challenges, yet safe and effective therapies are desperately needed for this vulnerable group. We conducted surveys and interviews with pediatric providers, investigators, and parents to determine barriers to conducting these trials and obtain suggestions for strategies to overcome them.
View the poster to learn more about our findings:
- Perceived barriers to conducting pediatric antibacterial drug trials
- The need for better engagement with parents
- Approaches for making studies child- and parent-friendly
- Strategies for improving communication and enrollment
These findings, along with multi-stakeholder input, are being used to generate recommendations to improve the quality and efficiency of pediatric antibacterial drug trials.