ABDD Peds Trials

CTTI Releases 2017 Annual Report: One Decade of Impact. One Vision Ahead.

Posted on by Lorri Bingham

CTTI’s 2017 Annual Report, released today, celebrates a decade of CTTI impact and highlights our activities and accomplishments over the past year. The report includes reflections from past and present CTTI leaders, case studies on the use of CTTI recommendations and resources, and a glimpse into what lies ahead for CTTI and the clinical trials enterprise.

Since its founding in 2007, CTTI has completed more than 25 projects with the aim of increasing the quality and efficiency of clinical trials. The resulting recommendations were downloaded more than 26,000 times over the past year.

CTTI issued five new sets of recommendations in 2017, many of which draw on recent advances in technology and data sciences to bring about improvements for clinical trials. Read the report to learn more about our latest recommendations and resources, which offer:

As described in the report, these recommendations and resources are being implemented by organizations across the clinical trial spectrum, including IQVIA, monARC Bionetworks, and the Pulmonary Fibrosis Foundation.

As we reflect on the past year—and the past decade—we are grateful for the engagement and commitment of our members, who ensure that we continue to address the latest trends, top barriers, and leading opportunities in clinical research.

CTTI Article Explores Facilitators and Barriers Perceived by Investigators to Successful Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Growing rates of antibiotic resistance have made the development of new antibacterial therapies an urgent public health need. This is especially true for the pediatric population, where it may take up to 10 years for clinical trials to determine safety and dosing information.

A CTTI article recently published in Contemporary Clinical Trials Communications shares findings from a survey of 73 investigators to determine facilitators and barriers to the successful conduct of much-needed pediatric antibacterial drug trials. The survey was conducted as part of CTTI’s Peds Trials work.

As outlined in the article, almost all investigators identified two factors as very important facilitators: having strong site staff and adequate funding. Other facilitating factors were related to staff expertise. Investigators rated parent concerns and obtaining consent as the most critical barriers. Other barriers included concerns about the number of blood draws and other invasive procedures, as well as having overly narrow eligibility criteria.

The survey findings suggest three areas in which to focus efforts to help facilitate ongoing pediatric antibacterial drug development:

  1. Improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial.
  2. Broadening inclusion criteria to allow more participants to enroll.
  3. Ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks.

These results were used to develop CTTI’s actionable recommendations for facilitating and improving antibacterial drug trials in the pediatric population.

CTTI Charts New Pathways for Pediatric Antibacterial Drug Development

Posted on by Lorri Bingham

In an article recently published in the Journal of the Pediatric Infectious Disease Society (JPIDS), CTTI researchers lay out a roadmap for addressing an urgent public health issue: pediatric antibacterial drug development.

Antibacterial drugs are critically important for treating infectious diseases, but growing rates of antimicrobial resistance have made the development of new antibacterial therapies a priority for researchers and physicians. The problem is especially acute in pediatrics, because even when new drugs are developed for adults, it may be up to 10 years before the pediatric clinical trials needed to provide vital information about safety, effectiveness, and dosing in children are completed. The result of these delays is a chronic shortage of information to guide the use of new therapies in pediatric populations.

The JPIDS article, which was distilled from the results of CTTI research and expert stakeholder meetings, identifies five key areas for action aimed at overcoming barriers to conducting timely and efficient trials of new antibacterial drugs in children, including:

  1. Improving planning for pediatric drug development
  2. Streamlining processes for protocol development and trial design
  3. Refining approaches to seeking and obtaining informed consent
  4. Engaging with healthcare providers
  5. Emphasizing the rapid incorporation of new information into product labeling

The article reflects recommendations from CTTI’s Pediatric Antibacterial Drug Development Project, which focuses on creating efficient, evidence-based processes for developing, testing, and using antibacterial therapies in children. The “Peds Trials” Project itself is part of the larger CTTI Antibacterial Drug Development Program.

By fostering collaborative approaches that involve all stakeholders, CTTI hopes to accelerate the development of safe and effective pediatric antibacterial drugs—and to equip physicians and other healthcare professionals with the information they need to make the best possible decisions for the health of the children under their care.

Two CTTI Papers Explore Perceptions on Enrolling Children in Clinical Trials

Posted on by Lorri Bingham

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.

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.

Perceived Barriers to Pediatrician and Family Practitioner Participation in Pediatric Clinical Trials: Findings from the Clinical Trials Transformation Initiative

Posted on by Hannah Faulkner

Perceived Barriers to Pediatrician and Family Practitioner Participation in Pediatric Clinical Trials: Findings from the Clinical Trials Transformation Initiative

CTTI Shares Challenges and Solutions to Enrolling Participants in Pediatric Trials at AAP 2017

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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.