New drug applications to the European Medicines Agency (EMA) require a Paediatric Investigation Plan (PIP) providing information about the likely use of the drug in children of all ages. Often, the number of children with the disease that will be treated is described, together with details of the use of treatments currently available in children. Potentially, the Clinical Practice Research Datalink (CPRD) and linked Hospital Episode Statistics (HES) provide a valuable tool to support PIPs. However, describing disease with very specific age-classes is often difficult in data sources where date of birth is removed as part of the anonymisation process. This study aims to better understand illness in the very youngest patients by 1. Assessing methods to accurately estimate age-classes, and 2. Understanding how health services are accessed in the first few weeks or months of life, and what information may be captured from this period within CPRD and HES. This study will be conducted in collaboration with CPRD's internal research team to consider any potential ethical questions around attempts to better approximate patient age.
Unless exempt because of a deferral or waiver, new drug applications to the European Medicines Agency (EMA) require a Paediatric Investigation Plan (PIP) providing data in children to support the authorisation of the medicine for paediatric populations. The potential for drug exposure in all paediatric age groups (neonates, Infant/Toddler, children and adolescents) is assessed and may be compared with adults. Often, the incidence and prevalence of the targeted disease is assessed to describe the potential paediatric population for any new medication. Potentially, CPRD and linked Hospital Episode Statistics (HES) provide a valuable tool to support PIPs. However, assessments requiring specific age-classes are often difficult in real world data sources where date of birth is removed as part of the anonymisation process. This study aims to better understand illness in the very youngest patients by 1. Assessing methods to accurately estimate age-classes, and 2. Understanding how health services are accessed in the first few weeks or months of life, and hence what information may be captured from this period within CPRD and HES. We propose to work closely with CPRD's internal research team to consider any potential ethical questions around attempts to better approximate patient age.
Estimated age; Distribution of neonatal jaundice and initiation of childhood vaccinations by estimated age.
John Logie - Chief Investigator - GlaxoSmithKline Research & Development Limited (UK)
John Logie - Corresponding Applicant - GlaxoSmithKline Research & Development Limited (UK)
Harriet Dickinson - Collaborator - GSK
Iain Gillespie - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Oksana Kirichek - Collaborator - GSK
Rachael Williams - Collaborator - CPRD
CPRD Mother-Baby Link