IMI ConcePTION recommendations published on the data fields needed for pregnancy pharmacovigilance
Researchers from the Innovative Medicines Initiative (IMI) ConcePTION project have published a set of recommendations about the core data elements which should be collected when performing studies of medication use in pregnancy.
These recommendations include all the key variables that are required in studies assessing both immediate pregnancy/infant outcomes, and longer-term childhood outcomes following maternal medication use in pregnancy.
Each of the data elements included within the reference framework are described with a clinical definition, a recommended data format, an expected source (either collected or derived from other data elements), and an expected purpose. Individual data elements are also categorised as either essential or highly recommended where it was judged that outcome statistics could not be generated without their collection.
Lead author of the publication, ENTIS member, Dr Jonathan Richardson from the UK Teratology Information Service explained, “Studies which investigate medication safety in pregnancy need to provide key statements about outcome risks such as the number of exposed pregnancies which resulted in adverse outcomes, or the relative risk of adverse events in controlled studies. To be able to provide these statements, a core dataset of variables must be collected for each pregnancy, but currently there are limited guidelines for researchers about what data should be collected, and how these variables are defined. With this set of recommendations, we are hoping to make it easier for researchers to develop high quality data collection systems. A second but equally important aim of producing these guidelines is that they will help to standardise new data collection efforts so that data can be more easily combined between similar systems, allowing for a faster accumulation of safety information. We are also currently testing how feasible it is to convert the data of existing systems to this new data format, using the core data elements as a basis for a multi-safety surveillance system common data model.”
An article published in Drug Safety describes the process used to generate the recommendations, and provides the peer-reviewed first version of the recommendations. An online version of the recommendations is also available on the ENTIS website which can be searched and filtered (see here).