Periodic Reporting for period 4 - ConcePTION (Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation)
Periodo di rendicontazione: 2022-04-01 al 2023-03-31
Building on (1) the rising awareness of the problem, and (2) the exponential growth and innovation in capture and use of health, surveillance and digital patient-generated data, ConcePTION will create a paradigm shift in how we generate and disseminate evidence on the effects of medicine in pregnancy. We aim to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medicines used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing pharmacovigilance, modelling, routine healthcare, pregnant women and their children through a large network. Conception will validate non-clinical models that predict medicine transfer to breastmilk using a multipronged approach consisting of in vivo, in vitro and in silico models, and will establish the first Europe-wide research biobank to measure medicine levels in human breast milk.
In year 1, Use of the ConcePTION ecosystem (network, tools, data, common data model) was already adopted in two applications for public funding in the Netherlands (the AAAA study on the safety of anti-hypertensive drugs) and in Norway (PREGNANT-COVID), and the use is actively promoted and enquired by several private organizations. In year 2, the ecosystem was utilised through WP7; EMA/2017/09/PE/04 retinoids project, CONSIGN, ACCESS, Early Covid Vaccine Monitoring project), MINERVA project for EMA, VAC4EU, and LifeCycle. The WP2 Core Data Elements (CDE) was used by UK Epilepsy and Pregnancy Register and by TIS Leuven (Teratology Information Services) and exchange of expertise was carried out through WP2 with the global initiative VAMPSS and Ubomi Buhle South African Pregnancy Exposure Registry. In year 3 and 4, the ConcePTION project has made remarkable progress in various work packages, including the definition of evidence elements, conducting demonstration studies, developing models for studying drug effects, and establishing a data quality framework. Key milestones include the publication of core data elements for pregnancy pharmacovigilance, successful approval of demonstration projects, and the development of a knowledge bank and communication campaigns.