IMI’s GETREAL project delivered a range of new tools and resources for incorporating real-life data earlier into drug development and decision making processes. The aim of the GETREAL Initiative is to drive the adoption of these tools and so increase the quality of real-world evidence (RWE) generation in medicines development and regulatory /health technology assessment processes. Specifically, the project will set up a think tank comprising international thought leaders to discuss, assess and give recommendations on opportunities and barriers to the generation, use and acceptability of RWE. The members will also act as ambassadors for the use of RWE, engaging with key stakeholder groups to facilitate the uptake of the project outputs. The project will also set up a number of task forces to drive the development of specific GETREAL outputs in the areas of pragmatic trials; network meta-analysis and benefit-risk assessment; and statistical approaches for enriching clinical trials with real world data. Finally, the project will create a RWE research community including researchers with expertise in RWE generation as well as regulators, health technology assessment (HTA) bodies, physicians and patients. The community will provide feedback on guidelines, recommendations and white papers produced by the project.
GetReal Initiative
FACTS & FIGURES
| Start Date |
|
| End Date |
|
| Call |
IMI2 - Call 11
|
| Grant agreement number |
807012
|
Type of Action:
| Contributions | € |
|---|---|
| IMI Funding |
1 750 000
|
| EFPIA in kind |
1 350 688
|
| Total Cost |
3 100 688
|
Summary
Achievements & News
April 2020
New institute to act as catalyst for wider use of real-world evidence in healthcare decision-making in Europe
May 2021
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 healthcare decision-making in Europe. ###The Netherlands-based institute will 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.
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, and will be supported through a combination of membership fees, revenue from the GetReal Academy, and other programmes and grants.
Find out more
- Read the article in full
Participants Show participants on map
EFPIA companies
- Amgen Limited, Cambridge, United Kingdom
- Astellas Pharma Europe BV, Leiden, Netherlands
- Astrazeneca AB, Södertälje, Sweden
- Bayer Aktiengesellschaft, Leverkusen, Germany
- Eli Lilly And Company LTD, Basingstoke, United Kingdom
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
- UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
- Academisch Ziekenhuis Groningen, Groningen, Netherlands
- National Institute For Health And Care Excellence, Manchester, United Kingdom
- Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- L.A Sante, Epidemiologie, Evaluation Et Recherche L.A.S.E.R., Paris, France
- Vital Transformation, Wezembeek Oppem, Belgium
- Zorginstituut Nederland, Diemen, Netherlands
Patient organisations
- International Alliance Of Patient'Organizations, London, United Kingdom
| Participants | |
|---|---|
| Name | IMI funding in € |
| Academisch Ziekenhuis Groningen | 393 200 |
| International Alliance Of Patient'Organizations | 90 000 |
| L.A Sante, Epidemiologie, Evaluation Et Recherche L.A.S.E.R. | 210 000 |
| National Institute For Health And Care Excellence | 220 000 |
| Universitair Medisch Centrum Utrecht | 525 000 |
| Vital Transformation | 201 800 |
| Zorginstituut Nederland | 110 000 |
| Total Cost | 1 750 000 |
Diederick Grobbee
Universitair Medisch Centrum Utrecht
Elaine Irving
Glaxosmithkline Research And Development LTD