The GetReal Institute is a new entity created from the IMI GetReal Initiative. It will be a public- private partnership with a mission to realise, develop and promote innovative methods for the development and assessment of medical interventions, including medicines, focused particularly on the use of real-world data and evidence. The Managing Director, as the leader of the Institute, will be responsible for developing, and implementing the strategy of the GetReal Institute, promoting the vision and role of GetReal worldwide and overseeing the finance and administration of the organisation.

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The GetReal Institute will be the successor of the GetReal Initiative and will focus on Facilitating the adoption and implementation of real world evidence (RWE) in health care decision-making in Europe.

The GetReal Insitute will be a public- private partnership. Membership of the Institute will open to public bodies, regulators, academia, patient groups, industry and other interested parties. The work of the Institute will deliver: shared understanding and prioritisation of the most critical opportunities and challenges; case studies, demonstration projects, research publications; guideline recommendations where gaps exist; trusted translational resources for applying best practices and guidelines. Read the flyer with key points.

Aggregated Data Drug Information System (ADDIS): a data management and analytical tool for efficient and transparent evidence-based decision making in health care, including network meta-analysis and MCDA.

ADDIS is an evidence-based decision support system for health care policy decision making that concerns alternative treatment options. ADDIS has been under continuous development since 2014, and is largely feature complete, though we are always working to improve the platform and add features on request.

Visit the ADDIS website at: www.drugis.org.

GetReal is developing customisable courses that aim to give an understanding of current techniques, opportunities and challenges for the use of real-world evidence in medicine development.

Since 2017, GetReal is organising the online Real-world evidence in medicine development. At this moment we are developing two new courses: a course on pragmatic/real-world trials and a course on benefit risk decision making. We plan to launch these new course in Q2 of 2021.

The RWE Navigator is an educational resource about the potential issues in demonstrating relative effectiveness of new medicines, and to understand specific types of analyses or study designs using RWE that can support development of medicines.

With the increased availability of data, developments in analytical approaches and study designs and the emergence of adaptive pathways for the licensing and reimbursement, there has been growing interest in the use of real-world data in the development of new medicines. Using the RWE Navigator will help you to understand the challenges in demonstrating the relative effectiveness of new medicines, and what part real-world evidence may play in overcoming these challenges. Visit the RWE Navigator here.

After the successful release in 2017, we are pleased to announce that the Pragmagic Tool has been updated and renamed to the GetReal Trial Tool. The renewed design focuses even more effectively on the tool’s rich functionalities.

The GetReal Trial Tool offers you step by step guidance to evaluate the options and implications of introducing Real World elements in clinical trial design.

Over 100 professional experts from pharmaceutical companies, academia, HTA agencies, patient organisations, and regulators have collaborated in a combination of extensive literature review (references are provided in the tool), in-depth stakeholder interviews, pragmatic trial study team conversations & consortium member input and the content has been validated by a team of professors, clinical trial (operational) experts and epidemiologists.

The GetReal Trial Tool offers you an accessible and solid knowledge base to assess, design or discuss your clinical trial in the light of real world evidence generation. More informed decisions in trial design will lead to better results, and better evidence. This will benefit all of society, especially patients.

The tool remains open access and can be used without entering any trial information.

For more information, visit the new website: https://getrealtrialtool.eu/.

After the previous successful editions of the course ‘Real-World Evidence in Medicine Development: an online introductory course’, we are pleased to announce that the next edition is scheduled from 20 April until 12 June 2020.

During this interactive online course, you will learn about current techniques, opportunities and challenges for the use of real-world evidence in medicine development. The course will be supervised by leading academics involved in the IMI GetReal project. This is an ideal course for anyone who wishes to become familiar with the key issues in the areas of real-world data and wishes to broaden his/her expertise. This is course is particularly relevant for anyone working for pharmaceutical companies, regulatory authorities, HTA bodies, patients’ organizations, consultancy companies and academic institutions. As such, the course will facilitate discussion, interaction and mutual learning across all professionals involved in medicine development.

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Please don’t hesitate to contact us if you have any questions. We are always happy to assist you. Please also feel free to spread this message through your own networks.

GetReal Initiative hosted a stand at ISPOR (Europe): Copenhagen, November 2019

The stand attracted interest from various conference attenders. At the stand, we advertised the tools developed by GetReal: ADDIS, Trial Tool (formerly Pragmagic) and RWE Navigator, as well as the RWE education activities (remote learning course hosted by Elevate and the UMCU) and the ongoing work of the RWE Think Tank.

RWE was a hot topic at the conference, with a large number of CROs promoting themselves as having specific expertise in this area.

Thanks to all the people who visited our booth and please feel free to contact us at info@getreal-initiative.eu for any questions.

During ISPOR Europe 2019 Dr Sebastian Schneeweiss (Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine, Brigham and Women’s Hospital) publicly endorsed our RWE Navigator.

He feels the RWE Navigator is ‘enormously educational and it will help people to get a jump start into Real World Evidence’. In addition, it also clarifies many issues and confusions that people have and last but not least it will ‘help people design better studies’.

Please have a look at the RWE Navigator on https://rwe-navigator.eu/.

With a continuing series of educational courses, several functioning web platforms to harness real world evidence, and now, an extension of project funding for two years, GetReal is regarded as one of the Innovative Medicine’s Initiatives true success stories. Duane Schulthess from Vital Transformation speaks with Elaine Irving of GSK, who has been Driving the GetReal bus for three years, avoiding potholes, and keeping the wheels turning as the project’s coordinator.

After the previous successful editions of the course ‘Real-World Evidence in Medicine Development: an online introductory course’, we are pleased to announce that the next edition is scheduled from 9 September until 3 November 2019.

During this interactive online course, you will learn about current techniques, opportunities and challenges for the use of real-world evidence in medicine development. The course will be supervised by leading academics involved in the IMI GetReal project. This is an ideal course for anyone who wishes to become familiar with the key issues in the areas of real-world data and wishes to broaden his/her expertise. This is course is particularly relevant for anyone working for pharmaceutical companies, regulatory authorities, HTA bodies, patients’ organizations, consultancy companies and academic institutions. As such, the course will facilitate discussion, interaction and mutual learning across all professionals involved in medicine development.

Learn more

Please don’t hesitate to contact us if you have any questions. We are always happy to assist you. Please also feel free to spread this message through your own networks.