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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

Periodic Reporting for period 1 - 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)

Reporting period: 2019-04-01 to 2020-03-31

More than 5 million women get pregnant in the EU every year and more than 90% take at least one medicine during pregnancy. Yet there is almost no evidence-based information available on most medicines to guide a woman’s fully informed decision. Even less information is available regarding medicine exposure through breast feeding. As few as 5% of available medicines have been adequately monitored, tested and labelled for use in pregnant and breastfeeding women. On average, it takes an estimated 27 years to determine the teratogen status of a novel medicine. The field, while inherently difficult to study, has suffered from a lack of systematically gathered insights that could lead to more effective data generation methodologies. Fragmentation and misinformation abounds, resulting in confusing and contradictory communication and perception of risks by both health professionals and women and their families. Obtaining reliable safety information for pregnant or breastfeeding women can take 20 or more years to collect after a medicine is on the market, if it arrives at all.

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.
The first year ConcePTION focused on an assessment of available systems, data, and methods and constructing the foundations of all of the dimensions (societal and ethical, technical, data, evidence generation, communication & evidence dissemination and sustainability) of the new ConcePTION ecosystem. Much work was conducted that contributes to the workflow and building bricks of the ecosystem:

- Ethical and societal: Foundational work was conducted on the governance, privacy aspects and ethics of using such data within the ConcePTION ecosystem
- Technical: a task management system, catalogue and platform were identified, assessed and put in service to support the work in the ecosystem. A common data model was defined for routine health care and surveillance data. All work packages described their data collections, the modality of analysing and archiving data, and a distributed data network approach was set-up.
- Data: different data sources that would be able to provide evidence on effects of drugs in pregnancy and lactation were identified ranging from animals, pharmacovigilance data, data on reported pregnancies, data on congenital anomaly surveillance, registries, plus routine electronic health care data. For the latter, 20 data access providers covering data on more than 2 million pregnancies per year are actively engaged in implementing ConcePTION tools.
- Evidence generation: Protocols were written to collect and use data from the different data sources and to assess its quality
- Evidence dissemination: A baseline assessment and online survey was conducted on the way information is currently provided to pregnant women. This showed the lack of consistency about the advice that is currently provided online and the information needs of women.
- Sustainability: models for sustainability of the ecosystem were developed and several interactions with potential users of the ecosystem. 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 inquired by several private organizations. Tools are also re-utilized in EMA requested studies on retinoids and valproate.

Several task forces were created to align activities across the work packages: a definitions task force, a statistics task force and a communication task force.

The involvement of stakeholders plays a significant part in the acceptability of the ecosystem. Therefore, cross-stakeholder engagement needs and endorsement and adoption tools have been mapped.

To coordinate the ConcePTION consortium, scientific management is needed. In this first year, there has been a focus on implementing the governance infrastructure, creating core documents for the project, assuring the internal collaboration and providing overall management for the project. In addition to this, we assessed the project’s environment and its effects on the sustainability of the project, including identification and refinement of the needs of end-users, inventory of possible strategic partners, assessment of organisational needs and investigation of best practices amongst comparable initiatives.
In ConcePTION we believe there is an important societal obligation to radically and rapidly reduce uncertainty about the effects of medicine use during pregnancy and breastfeeding. Even though studies are performed to test the safety, quality and efficacy of medicines before launch, ConcePTION is the first large European project that specifically focuses on pregnant and breastfeeding women. The project unites an unprecedented 88 organizations from 22 countries around a common goal, including the European Medicines Agency, pharmaceutical companies, academia, public health organizations, and teratology networks. Through better use of existing health data from routine clinical practice together with enhanced methods to collect patient-reported data, and with new research capabilities to predict and measure maternal medicine in breastmilk, the team aims to close the knowledge and information gap that will in turn lead to improved healthcare for this underserved segment of the population.