Building a pregnancy pharmacovigilance model for the future: Can pregnancy data collected by ConcePTION partners be analysed using common standards developed by the ConcePTION project?

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This study will use data from different ENTIS databases, from prospective pregnancy registries, and from enhanced pharmacovigilance programmes. A descriptive comparison will be made of the various aspects of the different data sources.

Study drug and medical condition

• Medical condition to be studied:
  Multiple sclerosis

  Pregnancy

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1900

Study design details

• Main study objective:
  Within the broader aim of building a pregnancy pharmacovigilance model for the future the objective of this study is to determine whether pregnancy data collected by ConcePTION partners can be analysed using common data standards, common clinical and technical definitions, and common reporting algorithms developed by the ConcePTION project.
• Data analysis plan:
  The ability of each data access provider (DAP) to create an analysis dataset of elements conforming to the definitions of the Core Data Elements (CDEs) established in ConcePTION task 2.3 of Work Package 2 will be described and discussed together with the processes used by them. Using this dataset each DAP will be asked to populate pre-defined summary tables according to the guidance in the Statistical Analysis Plan. Summary tables include information on pregnancy cases reported, pending, lost to follow up, and those with known maternal characteristics and risk factors, and known pregnancy outcomes (pregnancy and fetal outcome including congenital malformation) by timing of exposure. The populated tables will be discussed regarding informal comparisons and comparability between the analyses provided by each DAP.