PediatricsOur commitment to advance the scientific investigation of medical therapies in children begins at the bedside. We know firsthand the limits and risks of providing treatments based on evidence generated through studies of adults. Through innovative design methods and data monitoring, the DCRI's Pediatrics team is leading the world in expanding the impact of pediatric research.
Protecting Our Most
The safety and well-being of children must be at the center of all pediatric clinical research. Our Pediatrics faculty ensures this at every step. They—along with our statistical faculty, site and data management experts, and project leaders—work closely with sponsors at all stages of a study to ensure accurate and efficient execution.
Unparalleled Pediatric Expertise
Our pediatric research experience ranges from pharmacokinetic studies in neonates to large multicenter trials in adolescent populations. We focus on:
- Central nervous system disorders
- Infectious disease/HIV
- Primary care
DCRI Releases White Paper Providing Guidance on Pediatric Research
DCRI pediatric researchers, in collaboration with members of the DCRI’s communications team, authored “Plan and Design With the Child in Mind: Global Pediatric Clinical Trials Network Recommendations and Insights for Sponsors of Pediatric Research.” To gain these insights, the team conducted extensive research with pharmaceutical companies via an online focus group, in-depth interviews, and in-person educational workshops during which DCRI researchers worked with companies to identify and address their specific pediatric research challenges.
Helping to Shape FDA Guidance
DCRI's Pediatrics team contributed to the FDA's draft guidance on research in newborns, which provided clarity on study design, data analysis, and drug dosing.
Developing Pain Measures for Children
DCRI investigators, in collaboration with Duke's Department of Population Health Sciences, are developing a set of endpoints and measures that will be used in clinical trials and spur development of new pain medications for young children.
Engaging Patients to Improve Pediatric Research
In partnership with DCRI’s Research Together program and the Bioethics and Stakeholder Engagement (BASE) Lab at Duke, Kanecia Zimmerman, MD, MPH, is conducting formative research to determine the best way to share thank you notes and study results summaries with caregivers and adolescent study participants in pediatric trials.
The Pediatric Trials Network
Most of our pediatric clinical trials are conducted through the Pediatric Trials Network (PTN), founded in 2010 with a $95 million contract from the National Institutes of Health (NIH). The PTN is a groundbreaking collaboration between the DCRI and several of the country’s preeminent pediatric-medicine experts, hospitals, and medical centers. Through the PTN we study the formulation, dosing, efficacy, and safety of drugs—as well as the development of medical devices—used in pediatric patients.
Every PTN study is closely examined to determine how to obtain the most valuable and generalizable results while minimizing the risk to participants. Over the last 6 years, we have enrolled more than 5,000 children in more than 30 studies. Data collected from PTN trials has already helped regulators to revise 10 drug labels for safer and more effective use in infants and children. By 2017, the PTN expects to submit pediatric data for more than 20 products to the FDA.
A Global Expansion
In October 2017, the DCRI and its strategic partners were awarded a grant from the U.S. Food and Drug Administration to establish a coordinating center for a Global Pediatric Clinical Trials Network (G-PCTN). The G-PCTN will support efficient pediatric clinical trials worldwide by developing scientific and operational infrastructure, fostering collaborative networks, sharing knowledge, and engaging stakeholders.
Pediatrics Leadership at the DCRI
Danny Benjamin, MD, MPH, PhD, completed his undergraduate degree, medical degree, and pediatric residency at the University of Virginia. Board certified in pediatrics and pediatric infectious disease, he completed pediatric infectious disease subspecialty training at Duke University and received a PhD in epidemiology from the University of North Carolina. His clinical and translational research interests are in neonatal infectious disease and neonatal pharmacology. In his role as a mentor for the Clinical Research Fellowship Program, he works to recruit, develop, and retain physicians committed to the scientific investigation of medical therapies. During his tenure as an advisor to the Food and Drug Administration on improved pediatric clinical trial design, Benjamin held a joint appointment as a medical officer and special pediatric consultant providing programmatic advice on pediatric research regulation.
DCRI Pediatrics Faculty
- Mara Becker, MD
- Michael Cohen-Wolkowiez, MD, PhD
- Rachel Greenberg, MD, MHS
- Kevin Hill, MD, MS
- Christoph Hornik, MD
- Priya Kishnani, MD, MB
- Karan Kumar, MD
- Jennifer Li, MD, MHS
- Laura Schanberg, MD
- Brian Smith, MD, MHS, MPH
- Emmanuel “Chip” Walter, MD, MPH
- Charlene Wong, MD, MSHP
- Kanecia Zimmerman, MD, MPH