The GetReal Institute will be a focal point for information and exchange on the use of RWE in the drug development process
A new non-profit organisation called the GetReal Institute, an outgrowth of the IMI-funded GetReal Initiative project, has been set up to drive the adoption of real-world evidence (RWE) in health care decision-making in Europe. The Netherlands-based Institute is intended to offer an independent, neutral meeting point where regulatory agencies, health technology assessment (HTA) bodies, patient organisations, partners from academia and industry and data partners can work on reducing barriers to the secondary use of data sources for healthcare decision-making.
The Institute will tackle challenges related to data discoverability, quality, and accessibility, and issues relating to bridging the gap between RWE and conventional randomised controlled trial approaches. It will act as an ‘incubator and design lab’ where scientific and operational uncertainties relating to generating, evaluating and using RWE can be worked out, while also offering education and training resources through the GetReal Academy. At the launch event on 28 April 2021, the founders stressed the uniqueness of the venture, in that it’s the only European multi-stakeholder forum to offer a safe harbour to exchange and collaborate.
Real-world evidence: who needs it, and for what?
The job of a HTA organisation is to assess the value of a new drug. To do this, they need real-world evidence, which is defined as observational data obtained outside the context of randomised controlled trials, such as that generated during routine clinical practice. However, there is little guidance on how to generate RWE and integrate it into drug development. The IMI-funded GetReal (2013-2017) and GetReal Initiative (2018-2021) broke ground in that they brought together all the relevant stakeholders in order to begin to work towards building a consensus on best practices in the use of RWE in drug development, as well as regulatory and reimbursement decision-making.
The projects developed tools, recommendations and guidance for incorporating RWE earlier in the drug development process (see: GetReal Navigator, GetReal Trial Tool, and the Aggregate Data Drug Information System (ADDIS), and highly-regarded skills development training).
Any organisation involved in the generation, evaluation, or use of RWE may join the GetReal Institute. It will operate as a not-for-profit member association in the Netherlands, and will be supported through a combination of membership fees, revenue from the GetReal Academy and other programmes and grants.