Description
Key objectives of the project
The main goal of ConcePTION is 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 medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network.
To realise ConcePTION’s ambition the following key objectives are being addressed:
1. Build the societal and ethical dimension of the ecosystem:
ConcePTION will engage and co-create with pregnant women and their families, and all stakeholders, including healthcare providers, regulators and members of society, about information needs, ethical issues and potential solutions.
2. Build the technical infrastructure dimension of the ecosystem:
Data sources will be characterized in a FAIR data source catalogue, create semantic harmonisation models and common data models to make data interoperable, create open source analytical tools, use a secure data sharing platform, design and operate a harmonised European drug information knowledge bank for uniform and transparent dissemination of evidence, and provide e-learning facilities.
3. Build the data dimension of the ecosystem:
ConcePTION will identify, catalogue, harmonise and assess the quality of existing and novel health data sources and explore new sources such as digital data from pregnant women and social media. We will also set up a milk and blood samples biobank from breastfeeding women.
4. Build the evidence generation dimension of the ecosystem:
Transparent workflows, procedures, tools using consolidated governance models will be generated to transform data into actionable evidence resulting in better and timely information on medication use during pregnancy and breastfeeding.
5. Build the communication & evidence dissemination dimension of the ecosystem:
ConcePTION will provide training, organise stakeholder workshops, write scientific publications, conduct policy roadshow, organise public debates in lay language, create a digital knowledge bank and communicate through social media.
6. Build the sustainability dimension of our ecosystem:
ConcePTION will leverage the trust, cooperation and products that will be built during the project between and by the partners to continue evidence generation and dissemination on drug use and safety in pregnancy and breastfeeding.
Project Design
ConcePTION is designed to have 8 work packages (WPs).
WP1-4 address generation of evidence from different underlying data sources.
WP1 uses existing health data, e.g. from healthcare databases and registries to generate evidence.
WP2 generates evidence from reported exposed and non-exposed pregnancies by either women or healthcare providers.
WP3 will focus on in vitro, in vivo animal models, and modelling and simulation to generate evidence on transfer of drugs in breastmilk,
WP4 will focus on setting up the first European human breast milk biobank and collect milk samples from breastfeeding women.
WP5 will focus on summarizing all the available and generated evidence in a knowledge bank and disseminate information to women and healthcare providers.
WP6-8 Work packages on the outer circle are facilitating work packages.
WP6 is designed to coordinate and manage stakeholder engagement
WP7 is facilitating the rapid generation of high quality evidence in WP1 and 2, by providing governance rules, ethical standards and an IT infrastructure for harmonisation and data sharing and detailed characterisation of data sources.
WP8 deals with project management, scientific coordination and sustainability of the ecosystem.
More detailed information on our Work Packages