Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).
The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID. The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children. The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome).
Data from the POP02 study was used to develop and pilot tools leveraging the Health Level Seven International® (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard. These are new tools and resources that will advance and accelerate the rapid release and accessibility of pediatric COVID-19 clinical data.
The first batch of POP02 data (representing 57 participants) has been released using a newly launched FHIR Application Program Interface (API), in cooperation with the Kids First DRC. A second batch of data will be released in the coming weeks.
According to Emmes’ Vice President of Maternal and Child Health, Ravinder Anand, Ph.D., “The FHIR API is the first-of-its-kind implementation for near real-time, secure release of pediatric COVID-19 data. Before our partnership with Kids First DRC, Emmes had developed FHIR APIs across multiple cloud platforms to easily accommodate the addition of ongoing semantic information. The Kids First cooperative effort required mapping the data collected in the POP02 study case report forms to existing FHIR resources and incorporating additional terms from a variety of health sources, such as SNOMED Clinical Terms.”
Valerie Cotton, deputy director of the Office of Data Science and Sharing at NICHD, said, “Rapidly sharing pediatric COVID data using interoperability standards accelerates research that will help understand the impact of the pandemic on children and design interventions. This effort is a model for how groups can collaborate to respond to public health needs.”
Emmes’ work to support the POP02 and its participation in the CARING for Children with COVID project grew out of its existing role as the Data Coordinating Center for studies conducted under the Best Pharmaceuticals for Children Act (BPCA). Results from these clinical trials have contributed directly to improved drug labeling for a range of products used in treating infants and children.
“Our role as Data Coordination Center for the Best Pharmaceuticals for Children Act dates back to 2009,” noted Emmes Chief Executive Officer, Dr. Christine Dingivan. “Now, with this newer work, we’ve widened our focus from supporting the safe drug development in children to the international priority on how to combat pediatric COVID-19.”