Before I share details about GetReal, let me first outline our evolution. The GetReal Institute was established as an independent and sustainable continuation of two Innovative Medicines Initiative (IMI) projects. IMI GetReal ran between 2013 and 2017 with a focus on bringing together stakeholder groups to develop new tools and resources for incorporating real world data into drug development. Subsequently, the IMI GetReal Initiative ran between 2018 and 2021 to drive the adoption of these tools to improve the quality of real world evidence (RWE) generation in regulatory and health technology assessment processes. Both projects emphasised a collaborative approach to producing research outputs, thereby laying the foundation for the GetReal Institute.
To this end, GetReal published about 40 research papers on study design, methods and use; practical tools such as the RWE Navigator, the Aggregate Data Drug Information System (ADDIS) and the Trial Tool; and educational training for individuals and organisations was provided through the GetReal Academy to help scientists and researchers form a deeper understanding about the value of real world data (RWD) in developing medicines.
With this rich foundation in place, we formally established the independent, member-led, not-for-profit GetReal Institute legal entity in Utrecht, the Netherlands in April 2021. We then spent the rest of the year to navigate through the legalities needed to build an initial multi-stakeholder base that currently stands at twenty-six members. In fact, in May we announced the founding members, in July we posted news on our first Managing Board, and earlier this week on our first Chair and Treasurer appointments.
With the initial member base on-boarding completed, we’re now poised to start delivering against our mission: to facilitate the adoption of real world evidence in healthcare decision-making in Europe. It’s very gratifying to have seen GetReal’s evolution through to this stage and be working with colleagues who truly embrace such a true spirit of collaboration.
GetReal and EHDEN have actually been collaborating on several fronts, such as cross-promotion of their Academies with others to amplify the educational opportunities, and perhaps most importantly, bringing together communities and enabling them to speak for their respective stakeholders, thereby forming a hub committed to bridging the gap between clinical research and RWE with openness and neutrality. For example, we’ll be hosting a joint workshop on 31 October: ‘Regulators are formally adopting real world evidence, when will health technology assessment?’
The path forward
One of GetReal’s overarching goals is to ensure equity for these different voices, which is a challenge at this early stage, especially where stakeholder representation is limited in some areas. This being said, we’re confident that the foundation in place since 2013 gives GetReal the credibility to be considered a “trusted brand” and will serve us well as we move forward, set new targets and achieve new milestones. How we engage with our members and facilitate their participation in projects is one of the keys that will no doubt contribute to our collective success.
On that note, we’ve identified three focus areas where we can make an impact:
- Reducing barriers to the use of secondary data sources
- Bridging the gap between RCTs (Randomised Controlled Clinical Trials) and RWE
- Addressing evidence needs of downstream healthcare decision-makers.
To deliver against these focus areas, three initial projects were identified by experts from our membership:
- Develop recommendations or guidelines on the use of external comparators to complement clinical trial data for regulatory, HTA, and payer decision-making.
- Establish criteria for when results from RWE are sufficiently compelling to be used as pivotal evidence that impacts regulatory assessment.
- Develop a multi-stakeholder shared learning forum for RWE as a component of a broader “test and learn” environment in Europe that allays perceived risks in investing in and relying on RWE.
These projects are in various stages of development and we’ll be sharing updates on their progress on our website in due course over the coming months.
Back to the future
I was asked in a recent Voice of EHDEN podcast, if I were to look back in five years from now, what do I think success for GetReal would look like and what changes would I like to see in the European landscape?
Before pondering the next five years, I think it’s important to first recognise the significant progress made over these last five years. For example, profound strides have been made in harmonising what has historically been disparate RWD to a common data model such as OMOP; federated data partner networks like EHDEN and others are being built across Europe; awareness from a policy perspective from governments, regulators, HTAs and patient organisations has increased dramatically; and the range of analytical tools and training materials available is ever-expanding. And most importantly, thanks to this progress, the transformational potential of RWD/RWE is starting to have a meaningful impact on medicines and treatments.
So, if I can look back in five years from now, I’d like to see that a broad range of stakeholders has been able to synthesise and benefit from all of these advances, and as a result, has a much clearer picture of where we’re heading. From a GetReal perspective, it would be very rewarding to know that the work we’ve done has had an impact and has improved healthcare systems and patient outcomes – and that the benefits of collaboration and open science are clear across the stakeholder spectrum. And to bring this back to the present, working together to plan for this future now, will go a long way towards ensuring we reach our common goals.