PTN Post | Issue 38

Issue 38 | December 2022

Hello from the PTN,

The conclusion of a year brings the unique opportunity to reflect on recent accomplishments, while also determining a path forward.

2022 has certainly been a year that has brought about unique circumstances, but PTN has risen to the occasion. I am immensely grateful for the flexibility, creativity, and dedication shown by the Network. Within this final 2022 newsletter, you will find highlights of some of our most recent achievements.

I also hope you will check out our Annual Report, slated to be released in early 2023, to learn more about our successful year. If you know of content that should be included in the report, please reach out to Meagan Daly ([email protected]).

Our team is also working with our partners at iCAN to produce an anthology that will highlight the significance of pediatric clinical research through the lens of those most impacted-our children. If you are interested in contributing content and/or would like to learn more, please reach out to Meagan Daly ([email protected]).

Thank you for all the contributions you make to making drugs safe and effective for all children.

I hope you have a wonderful holiday season with those you hold close.

Danny Benjamin, MD, PhD, MPH

Pediatric Trials Network, Principal Investigator

Rachel Greenberg, MD, MB, MHS

Pediatric Trials Network, Steering Committee Chair

The Work of the PTN Recently Highlighted by Clinical Pharmacology & Therapeutics

The work of the Pediatrics Trial Network (PTN) was recently highlighted in an editorial by the Editor-in Chief of Clinical Pharmacology & Therapeutics, Dr. Piet Hein van der Graaf of Leiden University.

The editorial, which highlights examples of diversity in clinical pharmacology, features a PTN-led study and resulting publication titled: “Use of Real-World Data and Physiologically-Based Pharmacokinetic Modeling to Characterize Enoxaparin Disposition in Children With Obesity.” This publication was included in the August issue of Clinical Pharmacology & Therapeutics.

PTN Continues to Inform FDA Label Changes

Under the Best Pharmaceuticals for Children Act (BPCA), the PTN works to provide the Food and Drug Administration (FDA) with information to inform label changes with the necessary information to prescribe the most appropriate doses of the medications to children. As a result of research conducted through the BPCA program, led by the PTN, the following label changes have been made:

Acyclovir
Ampicillin
Caffeine
Clindamycin (2)
Diazepam
Doxycycline
Lisinopril
Lithium
Lorazepam
Mercy babyTAPE
2D and 3D Mercy TAPE
Meropenem
Propylthiouracil
Pralidoxime
Sodium nitroprusside

Kenneth McCall III, a middle schooler and iCAN participant, discusses the importance of PTN research.

Thanking Trials Participants and Their Families

The Pediatric Trials Network (PTN) has sent thank you cards to thousands of trial participants and their families this summer recognizing the critical role families play in advancing pediatric research. PTN has sent thank you notes domestically and internationally, translating the notes into foreign languages when appropriate.

The thank you note is customized for each study that PTN is coordinating. For example, if blood draws are a requirement of the study, then blood draws and the associated frequency are explicitly mentioned in the thank you note so that participants’ contributions are specifically acknowledged.

Results-At-A-Glance

The Pediatric Trials Network works to make medications and medical devices safer and more effective for all children. As part of that work, we share what we learn with research participants and the general public through Result-At-A-Glance (formerly known as Lay Summaries). We appreciate every family who participates in research and makes this work possible.

Acyclovir Results-At-A-Glance

Ampicillin Results-At-A-Glance

Lisinopril Lay Results-At-A-Glance

Meropenem Results-At-A-Glance

POP01 Results-At-A-Glance

Caffeine Citrate Results-At-A-Glance

babyTAPE Results-At-A-Glance

Process for Sharing Data and Samples

PTN has an established process for requesting access to samples and/or data from its studies for additional testing. An investigator must access data and samples directly from the NIH Data and Specimen Hub (DASH). See the PTN Data Sharing page for more information.

PTN Studies Currently enrolling:

Learn more about each study via the links below

PTN Studies Recruiting soon:

Guanfacine for Hyperactivity in Children with Down Syndrome (HYP01)
Defining the Safety and Efficacy of Posterior Tibial Nerve Stimulation in Children
Methadone Pharmacokinetics and Pharmacodynamics in Adults
A Prospective, Open-Label Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma

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PTN is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and provides pediatricians, researchers, and regulators with new information on how children respond to medications.