We have observed many meaningful accomplishments from the Pediatric Trials Network since releasing our last newsletter in December of 2020.
We remain encouraged and grateful as we observe all the ways in which the network has responded to COVID-19, while not losing momentum on so much of our other important work. We are sharing some of those highlights with you below.
In case you missed it, we recently shared our 2019/2020 Annual Review. Please take a look here to check our most recent label changes, publications, and more.
As always, thank you for your commitment to the PTN.
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.
First Child with Down Syndrome Enrolls in PTN Study
This marks an exciting and significant milestone for the network. As part of the INCLUDE initiative, a directive from the National Institute of Health (NIH), PTN is committed to supporting clinical trials on conditions and diseases that affect people with Down syndrome, both to accelerate the development of new therapies for individuals with Down syndrome and to include them in ongoing clinical trials.
Enrollment Goal Rapidly Approaches for Digoxin Study
PTN's Digoxin studyis rapidly approaching an enrollment milestone for its unique study participant population. Digoxin’s original study timeline projected enrollment to be completed by the end of May 2021. However, due to the onset of the COVID-19 pandemic and related shutdowns and delays, the study team adjusted its target to finish enrollment by June or July of 2021. Through, teamwork, diligence, and determination the study team was able to meet the original target enrollment date, much quicker than anticipated after COVID-19 delays.
Safety, Preliminary Effectiveness, and Pharmacokinetics (PK) of Drugs in Infants (Infant Master Protocol)
Process for Sharing Data and Samples
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.
