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
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.