Clinical research organization (CRO) has announced it has been tapped as a data coordinating center on a team pursuing pediatric COVID-19 research via the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POP02). The team (led by Duke University’s Pediatric Trials Network) 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 among the 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.
According to the team, 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; the tools and resources reportedly will be used to advance and accelerate the release of pediatric COVID-19 clinical data.
To learn more about the project, Outsourcing-Pharma connected with two Emmes representatives:
- Ravinder Anand, vice president of maternal and child health
- Joe Sliman, chief medical officer
OSP: Could you please talk about what we know so far regarding the differences between how COVID-19 impacts children, versus adults? Feel free to talk about what we don’t yet know, too.
Emmes; Children can and do become infected with COVID-19 although statistically, they are less likely to become seriously ill or even to exhibit symptoms when compared to adults. Children with underlying health conditions appear to be among those at the highest risk of developing severe symptoms as a consequence of COVID-19 infection.
Children are at higher risk (compared to adults) of developing systemic or organ inflammation (Multisystem Inflammatory Syndrome in Children, or MIS-C) as a result of COVID-19 infection, although in most cases this does not lead to permanent organ damage.
While we do know that asymptomatic children can carry infectious viral particles in the pharynx, sometimes in excess of that found in symptomatic adults, this viral load is not correlated with infectivity. In other words, we do not know to what extent infected, asymptomatic children can spread the virus, only that it is possible, and that vaccination reduces transmission in both children and adults.
OSP: Please summarize what the team hopes to learn through this POP02 initiative.
Emmes; The primary objective of the POP02 study is to evaluate the pharmacokinetics of understudied drugs that are administered to children as per standard of care by their treating provider. This study will allow us to determine appropriate dosing for these drugs, including drugs used to treat COVID-19 infection such as remdesivir and anakinra, in different pediatric age groups. Additional data are collected for COVID-19 participants to better understand the clinical course of the disease and the safety profile of drugs used to treat COVID-19.
OSP: Could you please share some detail about Emmes’ role and contribution to this project?
Emmes: Emmes has operated as the BPCA Data Coordinating Center since 2009. The goal of the BPCA program is to provide practitioners with adequate labeling for the pediatric use of marketed medical products (if this is not otherwise contraindicated) and thus improve the safety and efficacy of the affected population. To date, the program has obtained 13 label changes and two marketing approvals (510(K)) for devices.
Over the past 11.5 years, Emmes has provided full-service clinical trials management to over 275 clinics for over 45 studies evaluating 130+ drugs in areas including:
- data system development, training, and maintenance
- data collection and quality
- network and study management
- statistical design, analysis, programming, and reporting
- safety monitoring and reporting
- support of the BPCA Data Monitoring Committee
- regulatory support, management, and submissions to the FDA
- central and site monitoring
- provision of final redacted datasets to the NICHD repository (DASH)
- expert consultation and support in protocol development
- active participation in relevant committees and meetings.