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Project overview
The INTEGRATE-LMedC consortium will develop a new concept to guide and support decision-making for the next-generation research infrastructure (RI) to facilitate efficient utilisation and harmonisation of large medical cohorts (LMedC), and to accelerate scientific and medical breakthroughs in Europe and beyond. Achievement of these ambitious objectives will only be possible through the integration of 11 highly interdisciplinary partners including established ERIC / ESFRI infrastructures such BBMRI, ECRIN, EIRENE and EBRAINS with unique expertise in conceptualising and implementing European RIs. An overarching RI concept to manage, integrate, and sustain LMedC studies will be developed, including an initial financial and operational plan for the implementation of the new RI outlining new services and access opportunities for the research community.
The project is structured in16 work packages (WP):
- WP1 – Project Management and Coordination, period 1
- WP2 – Outreach, period 1
- WP3 – Large Medical Cohorts
- WP4 – The current European RI-landscape
- WP5 – Quality Measures
- WP6 – ELSI, FAIR and fairness
- WP7 – Project management and coordination, period 2
- WP8 – Outreach, period 2
- WP9 – Data stewardship and sharing models
- WP10 – Information security
- WP11 – Data harmonization: FAIR catalogue
- WP12 – Data harmonization: demonstrator analyses
- WP13 – Sound science case
- WP14 – Governance framework
- WP15 – Policy for Cohort access and Secondary data use
- WP16 – New concept and sustainability
The project was officially launched at a kick-off event in Trondheim, Norway, on 08 April 2024. Now, with the first six months completed, it is an opportune time to review the initial results from the work packages that have already started.
WP1 – Project Management and Coordination, period 1
At the start of each new project, it is the administration and coordination work package that has full hands. WP1 lead by NTNU and supported by BBMRI-ERIC was not exception to the rule. First steps were about to setup the communication platform Sharepoint and connecting all partners to it, followed by kicking off the project via online meeting and having an introduction chat with EU project officer. Big efforts were dedicated to in person meeting which was organised in rather short time and took place in April in Trondheim.
WP1 also prepared a management tool tracking all the deliverables and milestones in easy way, as well as the very first deliverable D1.1,Project Management Handbook, which serves as a guide book for all partners. The project manager also supported individual WPs in their needs to gather the partners and dealing with establishing responsibilities and schedules needed to achieve the results.
WP2 – Outreach, period 1
In the first six months of WP2, we undertook a comprehensive stakeholder mapping initiative, identifying key stakeholders such as scientists, research consortia, policymakers, funding bodies, industry representatives, health organizations, patient advocacy groups, experts from the humanities and social sciences, and citizens. This process was crucial to understanding their communication needs and ensuring effective engagement throughout the project.
Additionally, we developed a Dissemination and Communication Strategy Plan (DCSP), detailing all communication and dissemination activities for the project’s duration. The DCSP was tailored to address the specific needs and objectives of each stakeholder group. Our efforts also included the creation of the project logo, the development of the project website (currently being populated with content and partner biographies), and the establishment of social media channels (Twitter/X, LinkedIn) and this biannual newsletter. To foster collaboration and ensure cohesive and effective communication strategies, we organised two communications meetings in partnership with other project members.
WP3 – Large Medical Cohorts
The first step of our WP3 was to define large medical cohorts, which you can find below:
A medical cohort refers to a group of individuals with a shared condition or characteristic of exposure who might be followed over time to collect extensive health-related data and/or biological materials for current and future health research. The data and biological materials collected from a medical cohort are stored as databank and/or biobank collections. In this project, we neither consider interventional clinical trials nor databanks based on health registries without specific follow-up as medical cohorts. We consider a medical cohort as “large” if:
· A clinical cohort (observational) comprising over 1,000 participants selected for a health condition; or
· A rare disease cohort comprising over 0.5-1% (as a rough guideline) of the total disease population of the country; or
· A population cohort comprising over 10,000 participants.
In order to identify unmet medical needs and opportunities for improving medical care, we will conduct a Delphi study (2 rounds), aiming to reach 100 experts in the following fields:
- Physicians
- Primary care
- Health policy
- Public health
- Epidemiological research
- Cohort research
- Translational research
We are waiting for IRB approval to start the study, but we are finalising the documents in order to start the study as soon as we receive approval. We have already started filling in the spreadsheet for the identification of experts. Once the study is complete, we will have identified areas of unmet medical need that could benefit and improve medical care through large medical cohorts.
To carry out the gap analysis, we will map existing large medical cohorts in the areas identified in the Delphi study, in Europe, by means of a systematic review.
Based on the findings, we will then draft the deliverable to help guide more effective decision-making and research efforts, and support the development of a next-generation research infrastructure to streamline the use of cohort data and samples, now and in the future.
These are the current activities. If you are interested in getting involved, please contact us at hello@integratelmc.eu.
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