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Big Data for Better Outcomes, Policy Innovation and Healthcare System Transformation - Sofia ref.: 116055

Periodic Reporting for period 2 - DO-IT (Big Data for Better Outcomes, Policy Innovation and Healthcare System Transformation - Sofia ref.: 116055)

Reporting period: 2018-02-01 to 2019-01-31

Big Data for Better Outcomes (BD4BO) is a part of the public-private Innovative Medicines Initiative-2 (IMI-2). BD4BO is a research programme aiming to promote the development of value-based and outcomes-focused healthcare systems in Europe through the use of big data. Big Data for better Outcomes, policy Innovation and healthcare system Transformation (DOIT) is the coordination and support action (CSA) for the current BD4BO programme. The support action has several roles, including to define of overall programme strategy for BD4BO, manage and share knowledge from and between the different disease specific projects, act as a central point of collaboration and communication across BD4BO projects and provide minimum data privacy standards for informed consent forms and supporting materials.
The DO-IT consortium commenced work in February 2017 after a successful and well-attended kick-off meeting in Basel. In the first year of the project, a number of key deliverables were produced, and with a total of 36 partners and a complex project structure, the second year was used to strengthen the working relationships established so far with the BD4BO disease specific projects and achieve all the objectives set at the start of 2017. After being informed that no extension was granted, the DO-IT team set to work on sustainability measures that could ensure the visibility and maintenance of the work developed during the project by DO-IT and the BD4BO consortium. In this second year, the BD4BO knowledge hub was launched, and its sustainability for another year beyond the project timeframe was ensured by Bayer. The long-term guidance document was made available in October to consortium partners, and the outreach plan set in the first year was implemented. The final version of an informed consent form was also produced by Work Package 4. Other key activities included continually interacting with the BD4BO disease specific projects and creating channels to learn from each other, including through events and materials created by DOIT.
DOIT is a coordination and support action and the project is therefore focused on supporting the BD4BO programme and communicating disease specific programme outputs, rather than producing world-leading scientific outputs in its own right. Within this remit, DOIT aims to position BD4BO as a unique research initiative and has implemented activities to support this. BD4BO is a comprehensive research programme, encompassing projects in diverse disease areas that use different data sources (ranging from electronic health records to genomic data) and pursue different goals. DOIT has implemented a two-step process to create a common programme strategy for these diverse projects to maximise impact for patients and the wider society. A long-term programme strategy is essential to ensure the unique potential of this large research initiative is fully leveraged and a lasting impact is achieved. In this two-step process, an interim strategic guidance document was created in the first year, followed by a long-term guidance document in the second year, which ensures a long-lasting common identity for BD4BO. A unique international advisory board, consisting of stakeholders ranging from payers and HTA bodies to researchers and patients, contributed to the development of the long-term guidance. DOIT has launched a common online knowledge repository for the BD4BO programme. The repository serves as a common platform to facilitate knowledge exchange between individual projects, capitalising on the expertise and experiences of several large consortia working under the BD4BO umbrella. In a tiered user-access scheme, the repository will also be available to the public, ensuring that BD4BO outputs are accessible to other researchers and the interested public. The repository represents a key component in the programme’s sustainability solution and will ensure knowledge produced in this unique research initiative is preserved and made available to subsequent projects and the outside world.

Despite the focus on coordination and support activities, DOIT has implemented work that has the potential to achieve significant impact in healthcare systems and the research community. Firstly, work on a toolkit to identify and select core outcomes in real world settings has enhanced previous efforts to drive the outcomes agenda for healthcare system transformation. The toolkit’s focus on real world, as opposed to clinical trial, settings, and the extensive room given to regulatory and HTA body considerations when agreeing on core sets of outcomes in specific disease areas, represents an important step towards more widespread use of core outcome sets. This is expected to have a beneficial impact on healthcare systems through an increased focus on patient-relevant outcomes, more transparency and methodological rigour in the selection of outcomes, and comparability of outcomes across settings. Secondly, work on a template informed consent form that can be used for clinical research across Europe was concluded and can serve as a model for other ICFs. With a large consortium, including several world-leading pharmaceutical companies and sponsors of clinical trials, as well as public representatives, and two advisory bodies representing other research organisations and members of ethics advisory panels, agreement on minimum standards for informed consent has the potential to set an international standard for future data collection and use in the big data era. Ensuring research participants’ data privacy rights are respected while maximising the use of valuable patient data will enable the BD4BO programme and the research community beyond it to fully exploit the potential of big data.
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