GetReal Initiative

Summary

IMI’s GETREAL project developed new tools and resources to help advance the use of real-world evidence (RWE) in drug development and healthcare decision-making. RWE can help to increase understanding of, and confidence in, the safety and effectiveness of medicines and get them to the right patients more quickly. The GetReal Initiative was launched to refine and promote the adoption of the tools and best practices that were developed in the original GETREAL project, and to maintain and expand the community of researchers and other stakeholders that GETREAL had assembled. In order to increase the quality of RWE generation and advance its appropriate use in drug development and regulatory, health technology assessment and reimbursement practices and processes across Europe, the GetReal Initiative set up a self-sustaining non-profit entity – the GetReal Institute – that will maintain and build on the outputs of GETREAL, and provide training and access to the tools.

Background

Real-world evidence (RWE) refers to evidence on the benefits and risks of a treatment when used outside the tightly controlled environment of a conventional clinical trial. RWE plays an increasingly important role in drug development and offers great promise for use in regulatory practice, pricing and reimbursement, and clinical decision-making. However, historically there has been limited guidance on appropriate study designs, methods, and practices for generating RWE, and how to incorporate RWE into different decision-making contexts.

What’s more, the generation and interpretation of RWE requires particular skills and experience, which also vary greatly. There is still uncertainty as to whether or when decision makers will accept RWE in specific contexts. The original GETREAL project brought together key stakeholder groups together to build trust and community and identify the challenges and opportunities for generating and using RWE. GETREAL also developed a number of tools, ‘good practice’ recommendations, and other resources to support the development and use of RWE. However, there remains much to be done to fulfil the potential of RWE.

The GetReal Institute

The GetReal Institute is a platform for a diverse array of stakeholders to reach a common understanding of the opportunities and continuing challenges for the generation and use of RWE. It was designed to act as an incubator and ‘design lab’ for strategies and tools  to clarify scientific and operational uncertainties in RWE approaches and methods. It is also a source of trusted, high-quality RWE education and training resources, and a hub for connecting RWE-related initiatives from around Europe and beyond.

Established in May 2021 as a Dutch non-profit membership association, the GetReal Institute is open to any organisation, public or private, that is involved in generating, evaluating, or using RWE. Its governance body is elected and its funding model is based on membership fees, fees for training courses and licensing fees for RWE tools. One year after launch, the Institute had over 20 members from a diverse array of stakeholder groups, from academics and patient groups to regulatory and HTA organisations as well as pharmaceutical companies. The institute brings these members together to identify and share best practices and to explore potential collaborations with global and other regional initiatives and organisations.

Refined the tools: trial tool and ADDIS

The GETREAL project and GetReal Initiative created and refined tools to help people understand how to bring real world data earlier into drug development and decision-making. The GetReal Institute plans to manage, maintain and drive the adoption of these publicly-available tools.

• The RWE Navigator is an online educational resource on RWE and study designs and methods for generating RWE to support medicines development and use.
• The GetReal Academy offers a range of taught and self-paced online courses in RWE.
• The GetReal Trial Tool is open access and offers guidance on the options for and implications of introducing real world elements in clinical trial design.
• ADDIS (which stands for ‘aggregate data drug information system’) is a data management and analytical tool used to assist in evidence-based decision-making in healthcare.

Legacy and what’s next

The original GETREAL project successfully built a trusted name, forum, tools and framework for advancing our understanding of the generation and use of RWE. The GetReal Initiative built on the results of GETREAL and further refined the tools and resources. They also developed new relationships with experts and opinion leaders who had not been part of the original project, including those outside of Europe – expanding the GetReal community and scope of influence.

Crucially, the GetReal Initiative set up the GetReal Institute, which will promote the uptake of the tools and resources developed by the IMI projects and continue to advance the adoption of RWE in medicines development and healthcare decision-making in Europe and beyond.