Action grants to organise and collect data to understand the safety, quality and efficacy of therapies applied in the field of assisted reproduction and based on haematopoietic stem cells

EXPECTED RESULTS AND IMPACT
The expected results are new or substantially upgraded digital registries with higher quality data entries from medical professionals across the Union and Member States authorities. This will provide good quality data collection on therapies in the field of MAR and based on haematopoietic stem cells and facilitate data sharing for open science and for Union legal requirements for oversight purposes, for monitoring safety and outcome as well as for the protection of donors and offspring.

Proposed solutions should ensure the findability, accessibility, interoperability, and reuse of digital assets (FAIR principles), use or interoperate with the main European and global data standards and other initiatives (i.e. European Health Data Space, EOSC Life).

Qualitative data will be available for professionals as well as authorities and other stakeholders in the sector and facilitate their respective tasks in the sector (such as clinical protocols authorisations, market feedback, value-based reimbursement), while respecting the provisions on privacy protection (GDPR).

This will allow improving and promoting medical excellence, as well as increasing the efficiency of the healthcare systems and transparency for patients.

The action will have an impact on the digital transformation and uptake of digital solutions in the Union sector of MAR and hematopoietic stem cells, in order to facilitate the monitoring of activities and outcomes.

SPECIFIC MANDATORY DELIVERABLES AND/OR MILESTONES

• Documentation of the registry, using Unified Modelling Language (UML) including the data model, data flows, use cases and access by/for different stakeholders, in particular competent authorities
• Interoperability plan (use of standard taxonomies, data standards, links to open and European data assets)
• Implementation and investment plan
• Operational and financial plan

Management and Governance plan, including the role of national competent authorities in the long term sustainability.

SPECIFIC ACTION-LEVEL INDICATORS FOR REPORTING PURPOSES

Applicants will include the following specific action-level indicators and related reporting activities in their proposals:

• Number of professionals/centres participating
• Number of Member States covered
• Number of fields in the database
• Number of records treated by strand
• Number of data note deployed by strand
• Number of data exploited

POLICY CONTEXT

Hematopoietic stem cells play a significant role in the area of cancer immunotherapy, in particular in the treatment of liquid blood cancers like leukaemia and lymphoma.

Medically assisted reproduction (MAR) is a field of major and increasing importance, where shortcomings have been identified related to the protection of donors and offspring. In addition, MAR can also play a direct role in cancer care by sustaining fertility of young patients by preserving their reproductive cells for use in MAR after cancer treatment that would have rendered them infertile.

The action supports the policy priority to respond to the COVID-19 crisis and implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and of supporting innovation regarding such products as defined in (Article 3, point (c)) through the specific objectives defined in Article 4, point (c) of Regulation (EU) 2021/522.

OBJECTIVES
This action will aim to collect and organise in registries data on the safety, quality and efficacy of therapies applied in the field of medically assisted reproduction (MAR) and haematopoietic stem cell transplantation.

SCOPE AND ACTIVITIES

This action will support Union data collection, aggregation and analysis on the use and outcome of therapies in the fields of:

1. assisted reproduction;
2. haematopoietic stem cells.

For both (a) and (b) it will facilitate the design, development and management of dedicated IT solutions with and for medical/healthcare professionals.