WIREDGOV

NICE’s ambition complements the GetReal Institute’s core mission to facilitate the adoption and implementation of real-world evidence in health care decision-making.

NICE yesterday (Wednesday 28 April, 2021) announced it will join with nine other organisations to form the GetReal Institute as a founding member.

NICE’s new five-year strategy sets out how the organisation wants to have a leadership role in data, research and science. The strategy aim will involve driving the research agenda, using real world data to resolve gaps in knowledge and drive forward access to innovations for patients.

NICE’s ambition for this area complements the GetReal Institute’s core mission to facilitate the adoption and implementation of real-world evidence (RWE) in health care decision-making in Europe.

Joining NICE, the following organisations have expressed their intention to sign up as founding members (pending finalisation and execution of membership agreements):

• Clinical Practice Research Datalink (CPRD) (UK)
• Eli Lilly and Company
• Hoffmann-La Roche
• GlaxoSmithKline
• International Alliance of Patients’ Organizations (IAPO)
• Janssen, Pharmaceutical Companies of Johnson & Johnson
• National Institute for Health and Care Excellence (NICE) (UK)
• Norwegian Medicines Agency (NoMA)
• University Medical Center Utrecht (UMCU)

Additional participating organisations will be announced in due course.

The GetReal Institute will initially prioritise efforts in three areas:

1. Reducing barriers to using data that is generated in routine clinical practice in health care decision making, including addressing challenges with real world data discoverability, quality, and accessibility
2. Bridging the gap between RWE and conventional randomised controlled trial (RCT) approaches through, for example, incorporation of “real world” elements in RCT design and implementation, use of real world data-based external comparator arms in clinical trials, and use of non-interventional study designs
3. Addressing the evidence needs of "downstream" decision-makers -- HTA bodies, payers, clinical guideline developers, clinicians, and patients -- whose perspectives and decision contexts are as important as those of regulatory agencies.

Dr Felix Greaves, director of Science, Evidence and Analytics at NICE, yesterday said:

“NICE is highly regarded around the globe and is seen as a world leader in health technology evaluation and the development of clinical guidelines.

“Our involvement in the GetReal Institute fits very well with our newly launched five-year strategy and will benefit work in the Science, Evidence and Analytics directorate.

"As well as looking at evidence generation for pharmaceuticals, the GetReal Institute will have an opportunity to expand its remit to incorporate medical technologies and digital health interventions. These are two areas where NICE shares a mutual interest of better data and research.

“Our role within the GetReal Institute will enhance our ability to work with like-minded organisations to tackle challenges in the area of real world evidence which need unified support in order to ensure the needs of patients are met in 2021 and beyond.”

The GetReal Institute is a not-for-profit organisation and is based in the Netherlands.