NICE publish their new real world evidence framework
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UK: NICE publish their new, real-world evidence framework


As set out in the “NICE Strategy 2021-2026”, the National Institute for Health and Care Excellence (NICE) want to use real-world data (RWD) to “resolve gaps in knowledge and drive forward access to innovations for patients”. To support this, they developed a real-world evidence (RWE) framework, which was published Thursday 23rd June, accompanied by a launch webinar. 

The aims of the framework, as outlined by NICE, are to clearly describe: 

  • When and how RWD can be used to improve recommendations 
  • Best practices for planning, conducting, and reporting studies 

NICE have been clear that this framework should not be interpreted as minimum standards for real-world evidence studies but as best practice. They direct users of the framework to NICE’s methods guidance for more information on decision making. 

During the launch event, NICE summarised the principles of evidence generation that should be upheld when generating RWD. They are: 

  1. Transparency: Generate evidence in a transparent way and with integrity from study planning through to study conduct and reporting 
  2. Data suitability: Ensure data is trustworthy, relevant and of sufficient quality to answer the research question 
  3. Methods: Use analytical methods that minimise the risk of bias and characterise uncertainty 

The framework was developed collating research and existing best-practice guidance from other organisations and health technology assessment (HTA) bodies. A series of workshops and a public consultation were also held. NICE have specified that the framework will be a “living framework”, so continued updates are expected in the future. 

Sources:, NICE real-world evidence framework, 23rd June 2022 

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