The National Institute for Health and Care Excellence (NICE) in the United Kingdom sets benchmarks for excellence in healthcare standards. As described in the NICE strategy 2021 to 2026, NICE want to use real-world data (defined below) to resolve gaps in knowledge and drive forward access to innovations for patients. Therefore, incorporating Real World Evidence (RWE) into its health technology assessments (HTAs) can support committee member with their decision making. The framework covers all three stages of evidence generation, planning, conduct and reporting. This overview focuses on the NICE Real World Evidence Framework, highlighting its implications for health economics, preference, and outcomes research.
What is Real World Data?
Real world data can be defined differently by different organisations. However, NICE define real world data as "data relating to patient health or experience or care delivery collected outside the context of highly controlled clinical trial." This data can come from various sources including but not limited to patient registries, electronic health records, wearables, and observational studies.
What is Real World Evidence?
Real world evidence is evidence generated from the analysis of real world data. RWE can provide nuanced insights into patient outcomes, preferences, treatment efficacy, and economic impacts in real-world settings.
Objectives of the NICE RWE Framework
The NICE RWE Framework was created to:
Identify when real-world data can be used to reduce uncertainties and improve guidance
Clearly describe best practices for planning, conducting and reporting real-world evidence studies to improve the quality and transparency of evidence.
RWE Framework and Health Technology Assessment (HTA)
In addition to the above objectives, the RWE Framework aims to enhance the reliability and applicability of HTAs by integrating RWE with traditional clinical trial data. Some potential benefits of it's inclusion in HTA are:
Offering a deeper understanding of the long-term safety and effectiveness of treatments.
Alternative form of evidence, particularly valuable in areas where conducting randomized clinical trials (RCTs) is not feasible, such in ultra-rare disease.
Incorporating RWE ensures that NICE's guidance more accurately reflects real-world settings.
The framework provides detailed methodologies for using real-world data effectively in healthcare research. It outlines rigorous protocols for quantitative RWE studies, including transparent methodologies and advanced statistical analyses to ensure accuracy and minimize biases. The framework also guides on assessing data suitability, emphasising the importance of data quality and relevance for specific research needs. Additionally, it offers strategies for comparative effectiveness research, recommending appropriate study designs and analytical techniques for robust comparisons of healthcare interventions.
The framework provides several methodologies forming a robust foundation for conducting reliable and impactful RWE studies, essential for informed healthcare policies and practices:
Regulatory and Policy Implications
The framework significantly impacts regulatory policies and healthcare practices beyond guiding the collection and use of RWE. It plays a crucial role in guideline development, using RWE to address gaps in clinical guidelines and to update existing recommendations, ensuring they reflect a broader spectrum of patient outcomes. In healthcare policymaking, the framework influences the integration of economic evaluations, patient preference assessments, and outcomes research into the core of healthcare decision-making processes. Additionally, it fosters stakeholder engagement by promoting collaboration among healthcare providers, patients, and policymakers. This collaborative approach maximizes the effectiveness of RWE in enhancing health outcomes, ensuring that the framework's applications are as inclusive and impactful as possible.
DHT.health and RWE
Our team possesses extensive experience in conducting studies to generate real-world data, employing data science methodologies and statistical analysis to interrogate and analyse such data, and communicating findings through internal reports and scientific communications. We have the skill and experience to delver end to end preference and HEOR studies from conception to dissemination.
Conclusion
The NICE Real World Evidence Framework provide a clear guide to integrating RWE into healthcare evaluation and policy-making. By detailing methodologies for conducting quantitative studies, assessing data suitability, and comparative effectiveness research, NICE enhances the relevance and applicability of health technology assessments. As healthcare continues to evolve, this Framework will remain critical in shaping informed, effective, and efficient healthcare decisions within the UK and potentially across the globe.
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0%Data science to interrogate data
0%Statistical analysis to analyse data
0%Reporting and dissemination
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