The Clinical Research Organization (CRO) has announced that it has been used as a data coordinating center on a team that pursues pediatric COVID-19 research through pharmacokinetics, pharmacodynamics and safety profile of studied drugs administered to children per. care standard (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) launched 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 who are infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome). . Data from the POP02 study were used to develop and pilot tools that utilized the Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) standard; the tools and resources are said to be used to promote and accelerate the release of pediatric COVID-19 clinical data.
To learn more about the project, Outsourcing-Pharma contacted two Emmes representatives:
- Ravinder Anand, Vice President of Maternal and Child Health
- Joe Sliman, MD
OSP: Can you please tell us about what we know so far about the differences between how COVID-19 affects children, versus adults? Also, feel free to talk about what we do not yet know.,
Emmes; Children can and do become infected with COVID-19, although they are statistically less likely to become seriously ill or even show symptoms compared to adults. Children with underlying health conditions appear to be among those most at risk of developing severe symptoms as a result 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) due to COVID-19 infection, although in most cases this does not lead to permanent organ damage.
Although we know that asymptomatic children can carry infectious viral particles in the throat, sometimes in addition to those found in symptomatic adults, this viral amount 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 infection 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 studied medicinal products administered to children according to standard treatment of their treating provider. This study will allow us to determine the appropriate dosage 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: Can you please share some details about Emmes’ role and contribution to this project?,
Emmes: Emmes has served as the BPCA Data Coordinating Center since 2009. The goal of the BPCA program is to provide GPs with appropriate labeling for the pediatric use of marketed medical products (unless otherwise contraindicated) and thereby improve the safety and efficacy of it. affected population. To date, the program has achieved 13 label changes and two marketing approvals (510 (K)) for devices.
Over the past 11.5 years, Emmes has delivered full-service clinical trial management to over 275 clinics for over 45 studies evaluating 130+ drugs in areas including:
- development, training and maintenance of computer systems
- data collection and quality
- network and study management
- statistical design, analysis, programming and reporting
- security monitoring and reporting
- support from the BPCA Data Monitoring Committee
- regulatory support, management, and submissions to the FDA
- central and plant monitoring
- delivery of final edited data sets to the NICHD repository (DASH)
- expert advice and support in protocol development
- active participation in relevant committees and meetings.