Pediatric Antibacterial and Antifungal Trials From 2007 to 2017
Antibacterial Drug Development
CTTI Releases 2017 Annual Report: One Decade of Impact. One Vision Ahead.
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:
- Practical guidance for using mobile technology to develop viable novel endpoints for clinical trials.
- Best practices for assessing and designing registries for use in clinical trials so that the data can meet expectations for FDA review of new products.
- Actions that can be taken to strengthen the investigator site community and create an environment that sustains long-term investigator engagement.
- Guidance on planning for and making decisions about pregnancy testing in potential trial participants.
- Suggested ways to address the unique challenges of conducting pediatric antibacterial trials.
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
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:
- Improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial.
- Broadening inclusion criteria to allow more participants to enroll.
- 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
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:
- Improving planning for pediatric drug development
- Streamlining processes for protocol development and trial design
- Refining approaches to seeking and obtaining informed consent
- Engaging with healthcare providers
- 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
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 New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference
CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference.
On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent and enrollment in clinical trials. While early enrollment could improve the ability to conduct trials that evaluate the efficacy and safety of treatments for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), questions remain about implementing it ethically and effectively. CTTI will share findings from its HABP/VABP Studies Project on the acceptability of an early informed consent approach for high-risk patients and essential information that should be shared with key stakeholders.
On Wed., Nov. 8, CTTI will discuss findings from its MCT Legal & Regulatory Project on actual and perceived barriers that may be preventing the widespread use of mobile technology in clinical trials. Presenters will explore potential challenges and opportunities of conducting clinical research remotely, and solicit input from clinical enterprise stakeholders on potential ethics implications. The project is part of CTTI’s Mobile Clinical Trials (MCT) Program.
In a separate session, CTTI will also present findings to date for its Investigator Qualification project and Investigator Community recommendations. The presenter will examine whether current GCP training methods actually provide the knowledge and skills necessary to conduct quality clinical trials. Further, he will detail recently released recommendations that aim to strengthen the clinical trials investigator and study team community through better training and other approaches.
We hope you will join us in San Antonio, Texas, Nov. 5-8 as we share new insights into these noteworthy clinical trials topics.
Presentation: Stakeholder Perceptions on Early Informed Consent for Clinical Trials
Date & Time: Mon., Nov. 6, 3:30 – 4:45 p.m.
Presenters: Amy Corneli (CTTI) and Thomas Holland (Duke University)
Presentation: Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials, Legal, and Regulatory Project
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: David Babaian (Kinetiq), Linda Coleman (Yale University), and Jan Hewett (FDA
Presentation: Beyond Good Clinical Practice (GCP) Training: Expanding the Tool Set for Preparing Investigators
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: Gerrit Hamre (CTTI)