NICE RWE Framework: https://www.nice.org.uk/corporate/ecd9/chapter/overview

Real-world data (RWD) encompasses various types of information on patient health, care delivery, and experiences collected outside traditional clinical trials. This data is crucial in forming National Institute for Health and Care Excellence (NICE) guidance.

NICE utilises RWD to:

1. Characterise health conditions, care pathways, and patient outcomes.
2. Design and validate economic models related to healthcare.
3. Evaluate digital health technologies.
4. Address health inequalities.
5. Assess the safety of medical technologies.
6. Examine the effects of interventions on care delivery.

While Randomised Controlled Trials (RCTs) are preferred for studying interventions, they may not always be available or applicable to real-world NHS settings for various reasons, including ethical constraints, technical challenges, or lack of funding. Sometimes, RCTs may also have limitations such as irrelevant comparators, exclusion of important population groups, or poor quality, making them insufficient for NHS decision-making.

NICE often resorts to non-randomised studies, particularly for medical devices, public health interventions, and assessments of medicines. Observational cohort studies and single-arm trials with real-world external control are commonly used non-randomised methods.

NICE aims to use RWD more consistently to fill evidence gaps and expedite patient access to innovations. For RWD to be trusted, it needs to be gathered and analysed transparently, utilising fit-for-purpose data while mitigating biases.

NICE has developed a real-world evidence framework to guide the generation of high-quality evidence. This framework is targeted primarily at those creating evidence to inform NICE guidance but is also relevant for patients, data collectors, and evidence reviewers. Core principles for generating trusted real-world evidence include ensuring data quality, transparency, and the use of analytical methods that minimise bias.

The framework consists of several sections:

1. Introduction: Outlines the role and potential of RWD.
2. Study Conduct: Describes expectations for planning and reporting RWD studies.
3. Assessing Data Suitability: Provides guidelines for assessing the quality and relevance of RWD.
4. Methods for Real-world Studies: Offers specific recommendations for conducting non-randomised studies.

Companies are encouraged to seek early advice from NICE on integrating RWD into their evidence-generation plans.

In summary, RWD has become an essential tool for improving healthcare outcomes and policy, fulfilling NICE’s strategic ambitions to drive innovation and resolve gaps in knowledge through robust, transparent, and high-quality evidence.