By Niklas Blomberg, IHI Executive Director, and Magda Chlebus, Executive Director - Science Policy & Regulatory Affairs, EFPIA
Many of the challenges of modern healthcare are too big to solve alone. This is the spirit that inspired the launch of the Innovative Medicines Initiative (IMI) in 2008 and its successor, the Innovative Health Initiative (IHI), in 2021. Together, health research partners in the public and private sectors have delivered projects that are improving the lives of patients. More than that, they are working to remove bottlenecks that slow the progress of medical science.
A key feature of our experience since 2008, has been the growing importance of health data. Now, more than ever, precompetitive collaboration means sharing data. And, with the European Health Data Space on the horizon, patient data will remain centre stage in future.
However, for all partners, sharing health data raises legal, technical, data protection, ethical and intellectual property challenges. Despite these challenges, large volumes of data are being shared by public and industry partners in IMI/IHI projects. Participants have confronted the challenges and found ways to work together in the interest of patients, while meeting their responsibilities.
For example, eTRANSAFE developed the ToxHub platform, which brings together preclinical and clinical databases in an integrative data infrastructure, combined with innovative computational and visualisation tools. The HARMONY Big Data Platform is a governed data lake created to speed up haematology research. It is a best-practice-based platform where data submitted from various sources – once harmonised and anonymised – create a cohesive data repository ready for scientific research.
So we have seen real progress. The problem is that navigating data sharing can take time and energy – valuable resources that scientists would prefer to spend on generating knowledge and turning it into solutions.
Removing these kinds of common bottlenecks is precisely the kind of problem that the IMI/IHI were designed to solve. If we can identify standardised ways of solving the data puzzle, it will provide a catalyst to all future initiatives.
Introducing the Data Sharing Playbook
That is where the new Data Sharing Playbook comes in. Drawing on the vast experience of researchers who have worked on pre-competitive projects, the Playbook aims to accelerate data sharing by moving data to the centre of the planning stage.
It captures the experience and collective wisdom of scientists who have travelled this road before. The Playbook addresses the complex reality of sharing data, including participants’ need to implement internal procedures, regulatory mandates and technical processes. It acknowledges that working with health data is far from trivial, but solving these problems on a project-by-project basis is inefficient.
By shedding light on data sharing workflows and processes, identifying common roadblocks and proposing standardised solutions, the Playbook marks a turning point in unlocking the potential of data projects. It intends to be a user-friendly and comprehensive tool for all those involved in data sharing in IMI/IHI projects.
Instead of reinventing the wheel with every health collaboration, researchers now have a detailed and practical guide that allows them to hit the ground running.
Confront data challenges early
The Playbook takes the user through the data sharing journey from the outline of the IMI/IHI topic and proposal preparation to the negotiation of the grant and consortium agreement and project execution.
A central message is to start early. This means defining data sharing from the outset, while frontloading decisions on a Data Management Plan as soon as practicable.
In the topic writing phase, project participants can identify which type of data will be needed to answer their research question. A consortium should decide on a data sharing model early (whether that is centralised, federated or a hybrid approach), and select an appropriate data anonymisation strategy.
Starting early also provides opportunities to engage internally with colleagues whose support may be required – academic leads, lawyers, and data protection officers among others. This reduces the risk of running into problems down the line.
Along with practical and procedural steps, a cultural shift is required: organisations must view sharing as a means of unlocking the power of data for all partners. From there, participants can create a compelling business case to show internal colleagues the added value of data, and where necessary, assign a value to this data as part of IHI partner’s in-kind contribution to a project.
Data Sharing Playbook Masterclass
The Playbook has been developed not because data sharing is simple, but because it can be complex. To help participants to use it to unlock the value of data more swiftly, IHI will host a masterclass workshop on 4 September.
The masterclass, like the Playbook itself, aims to facilitate data sharing to deliver greater value for all partners. And, ultimately, to answer the health questions that patients, health systems and society want our community to solve.
