Making drugs safer and more effective for use in the youngest populations.
Issue 36 | March 2021
Greetings from the PTN!
The PTN team encourages you to read the 2020/2021 Annual Review. The Annual Review is a recognition of all our hard-earned accomplishments.
Studies such as PTN’s Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) Study continue to make strides in supporting the treatment of younger COVID-19 patients and is currently evaluating several therapeutics to potentially treat COVID-19 pediatric patients younger than 21 years of age. In fact, POP02 has been engaged in a multi-institution, multi-study collaboration with the National Institutes of Health (NIH) called The Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID (CARING for Children with COVID). This collaboration has worked to make de-identified data (or data that cannot be linked to a person’s identity) from children with COVID publicly available, in order to accelerate research on this important topic. The POP02 team was the first study to reach the important milestone of submitting these data and having them become available, and it is a testament to their tremendous effort and dedication.
Additionally, this year PTN has released more than 20 publications and informed new label changes for clindamycinand diazepam.
As always, thank you for your commitment to the PTN. We are grateful for the opportunity to partner with you as we make drugs safer and more effective for use in the youngest populations.
PTN remains committed to playing an active role in the response to COVID-19. From studying multi-inflammatory syndrome (MIS-C) in children, to updating the existing POP02 study to include participants with COVID, PTN has played an integral role in COVID-19 research.
World Down Syndrom Day is a time to bring global awareness to Down syndrome, a condition where a child is born with an extra chromosome. According to theCenters for Disease Control and Prevention (CDC), about 6,000 children in the U.S. are born with Down Syndrom each year. This is a condition that can cause mental and physical challenges for children that persist throughout their lifetime.
The PTN is committed to research initiatives that address the critical health and quality-of-life needs for individuals with Down syndrome across their lifespan. In partnership with the Duke Department of Pediatrics, the PTN INCLUDE project aims to support clinical trials on conditions and diseases that affect people with Down syndrome.
Throughout the PTN INCLUDE project, researchers will aim to establish the safety, efficacy, and dosing data of understudied off-patent drugs that are administered to children and young adults with Down syndrome. Additionally, researchers are developing a training program for clinical researchers and clinicians that are focused on Down syndrome individuals. This will allow more insight into providing patient care, and guidance for clinical researchers for the recruitment and engagement of Down syndrome clinical trial participants. Read more here.
Lay Summaries
The Pediatric Trials Network works to make medication 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 lay summaries. We appreciate every family who participates in research and makes this work possible.
Have you heard? PTN has a new 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). Seethe PTN Data Sharing page for more information.
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.
