NICE are hosting a launch event for its ‘Real-World Framework’ which describes best practices for the planning, conduct, and reporting of real-world evidence studies. The framework aims to improve the quality of real-world evidence informing NICE guidance. Real-world data refers to data collected outside of highly-controlled trials. It can come from many different sources including patient health records, administrative records, patient registries, surveys, observational cohort studies and digital health technologies.
Some interventional studies, such as pragmatic clinical trials, can also produce real-world evidence. Such trials may also make use of real-world data sources to design trials, recruit participants or collect outcome data
The Framework will resolve knowledge gaps and drive forward patient access to innovative treatments by:
- identifying where real-world data can be used to reduce uncertainties and improve guidance
- clearly describing best-practices for the planning, conduct, and reporting of real-world evidence studies to improve the quality and transparency of evidence
It is structured as follows:
- the introduction provides background on real-world data and real-world evidence, discusses its strengths and weaknesses, and summarises current and potential uses within NICE guidance
- study conduct describes NICE’s expectations for planning, conducting and reporting real-world evidence studies, recognising that acceptability of evidence will depend on the type of evidence and other contextual factors
- assessing data suitability describes the information needed to assess data provenance and its quality and relevance for addressing specific research questions
- methods for real-world studies of comparative effects provides more specific recommendations for conducting non-randomised studies. These include traditional observational studies as well as clinical trials that use real-world data to form an external control
The online event takes place on Thursday 23 June, from 14:00-15:00 BST. Please find the Eventbrite registration page here. More information resources on the Framework can be found on the past Consultation page on the NICE website (*may contain expired or amended information).