Aetion and NICE Announce Collaboration to Explore Use of Real-World Evidence for Comparative Effectiveness Studies to Inform Clinical Guidance

Aetion announced a collaboration with the National Institute for Health and Care Excellence (NICE) to explore how real-world evidence (RWE) can be used to study real-world clinical effectiveness. The collaboration aims to evaluate how RWE studies can be used to fill evidence gaps and reduce uncertainties in NICE guidance development. In addition, the agency will evaluate the appropriate timing post-launch to conduct RWE studies on comparative effectiveness, and pilot tools for planning and reporting on the implementation of RWE studies.

“We are honored to help NICE further advance evidence-based decision-making,” said Carolyn Magill, CEO of Aetion. “Through the scientific rigor embedded in the Aetion Evidence Platform, NICE can more easily integrate high quality RWE into decisions ranging from health technology assessments to clinical guidance development.”

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Global regulatory and health technology assessment (HTA) bodies are increasingly using RWE to answer questions on the utilization, safety, and effectiveness of medical treatments and technologies. In April 2021, representatives from NICE, the EMA, and Aetion co-published a paper in the Journal of Comparative Effectiveness Research detailing a structure for organizing the current fragmented RWE recommendations in order to achieve comprehensive guidance.

This collaboration marks Aetion’s first partnership with an international HTA body, and comes on the heels of the company’s research collaboration agreement with the U.S. FDA to use real-world data to study COVID-19, and the company’s selection by the Institute for Clinical and Economic Review as its preferred RWE partner and platform.

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“As NICE continues to deliver on our five-year strategic vision, including rapid, robust, and responsive technology evaluation, understanding how to make the best use of RWE is vital in helping us resolve gaps in knowledge and driving forward access to innovations for patients,” said Páll Jónsson, Programme Director – Data, who is leading the collaboration for NICE.

The collaboration will leverage NICE’s leadership in developing evidence-based technology appraisals and clinical guidelines as well as Aetion’s expertise in generating decision-grade RWE. Aetion and NICE will make use of Cegedim Health Data’s The Health Improvement Network (THIN) database to power analyses on the Aetion Evidence Platform.

Aetion is a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) designated research center, and contributes to the ENCePP Working Group 3, whose focus is to inventory EU data sources and define methodological approaches for multi-source studies.

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