Real-world evidence framework feedback

This consultation closed on:

29 April 2022


The NICE Strategy 2021 to 2026 states our ambition to use real-world data to resolve gaps in knowledge and drive forward access to innovations for patients.

To help deliver on this, we have developed the real-world evidence framework. This 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 our guidance. It does not set minimum acceptable standards for the quality of evidence at this stage.

It is mainly targeted at those developing evidence to inform NICE guidance. It is also relevant to patients, those collecting data, and reviewers of evidence.

We are currently revising the framework based on the consultation comments.

What happens next


  • a revised version of the real-world evidence framework will be published on 23 June 2022.


  • webinar on 23 June 2022 at 2.00pm.

Contact for more information.

Summary of objectives

  • clearly describe best-practices for the planning, conduct, and reporting of real-world evidence studies
  • improve the transparency and quality of real-world evidence used to inform NICE guidance
  • improve committee trust in real-world evidence studies
  • ensure real-world evidence is used where it helps to:
    • reduce uncertainties
    • improve recommendations
    • speed up access of patients to new effective interventions.