NICE updates real-world evidence framework to include new guidance on unstructured data and target trial reporting

The UK’s health technology assessment body, the National Institute for Health and Care Excellence (NICE), has revised its Real-World Evidence (RWE) Framework, introducing new guidance on the use of unstructured data and tools to support target trial reporting.

First introduced in June 2022, NICE’s RWE framework is widely regarded as a global benchmark for guiding the use of real-world data (RWD) and ensuring methodological rigor in RWE study design, conduct, and reporting. The latest revision, published in September 2025, represents the fourth update to the document and reinforces NICE’s commitment to maintaining a “living framework” that evolves alongside methodological developments and stakeholder feedback.

Among the most significant updates, NICE has added guidance on methods to support the use of unstructured data, such as imaging, laboratory reports, and clinical notes, recognizing their growing importance in modern evidence generation.

The new section, ‘Validity of information extracted from unstructured data,’ provides practical advice on ensuring the accuracy and reliability of information derived from such sources.

The framework states:

“Validation studies should be undertaken and reported for methods used to derive structured from unstructured data for analysis.”

It highlights the importance of documenting how unstructured data are processed and transformed into structured variables, including any algorithms or natural language processing methods applied. NICE advises that researchers “describe data pre-processing steps and additional transformation steps for unstructured data, such as conversion to machine-readable formats,” and report the results of any fidelity assessments.

Páll Jónsson, Programme Director Data and Evidence at NICE, commented that “NICE keeps updating best practice recommendations to ensure guidance can draw from the rich clinical data available.” Stephen Duffield, Associate Director – Real-World Evidence at NICE, added: “This update reinforces NICE’s commitment to keeping the framework relevant and responsive to the evolving data landscape – supporting better, evidence-informed decisions in health and care.”

The Data Suitability Assessment Tool (DataSAT) has also been updated to strengthen transparency and reproducibility. Developers are now asked to specify which data elements were extracted or derived from unstructured data and to provide details on their sources and validation processes.

Another key change is the addition of a new reporting tool for developers applying a target trial approach. The framework now references the TARGET Statement, recently published by Cashin, Hansford, Hernán et al. in JAMA. The guidance notes that availability of the checklist provide “guidance for reporting observational studies of interventions emulating a parallel group, individually randomized target trial.”

Finally, NICE has refreshed links to supporting resources and added reference to a Decision Support Unit (DSU) report examining the use of systemic anti-cancer therapy (SACT) RWD in health technology evaluations, underscoring the framework’s continuing focus on transparency, methodological robustness, and practical application.