Tender for Competition no.6: Methods and data sources for determining long-term effects of drug exposure during pregnancy, with application to antiepileptic medicines. EUROmediSAFE Consortium

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Other
• Study topic, other:
  Identification of sources of data and databases
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Identify sources of data
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Identification of sources of data and databases

Population studied

• Short description of the study population:
  N/A
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To identify potential sources of population-based cohort data for future studies
• Outcomes:
  Report: the inventory of data sources will consist of three parts, namely an inventory of data sources for in utero-exposure, an inventory of data sources for evaluating the long-term risks for children and (if possible) a preliminary investigation into the regulations governing the use of social media in the 28 EU Member States, To provide information for a study protocol to estimate the association between exposure to antiepileptic medicines in-utero and neurodevelopmental disorders in the offspring
• Data analysis plan:
  Tabulation of number of data sources per country and description of available databases