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AstraZeneca: Leveraging Real-World Data to Close Evidence Gaps in Clinical Practice 

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About the customer

AstraZeneca is a global biopharmaceutical company focused on the discovery, development and patient access of prescription medicines. Headquartered in Cambridge, UK and Gothenburg Sweden, AstraZeneca’s innovative treatments are sold in over 125 countries and used by millions of patients. 

The challenge

Andexanet alfa, an antidote for anticoagulants rivaroxaban and apixaban, was approved by the European Medicines Agency and made available in the Netherlands in 2019. After launch, clinicians sought detailed insights into its usage in routine clinical practice, including patient characteristics, concomitant medications, and treatment effectiveness. 

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Our solution

To address these gaps, AstraZeneca partnered with LOGEX to conduct a retrospective research project using real-world data (RWD). The project aimed to provide a comprehensive understanding of how andexanet alfa was used in the Netherlands, evaluate patient cohorts, and gather evidence on its practical effectiveness, also known as real-world evidence (RWE). 

Project Details

Ethical Approval: The project design, developed in collaboration with a steering group of clinicians, was approved by a non-WMO Advisory Committee. The project was fully compliant with all data protection laws and regulations. 

Data Collection: LOGEX analysed RWD from healthcare providers, capturing detailed insights into the drug administration and treatment. AstraZeneca received results on an aggregated level. 

Project Objectives: To describe patient characteristics, treatment strategy and outcomes of patients using andexanet alfa in a real-life setting. 

Outcomes

Insights for Clinicians: The project provided critical insights into practical use cases, aiding treatment decisions. 

Reliable Insights: A clinical study1 that was carried out around the same time, showed consistent results compared to the RWD study, confirming the reliability of these RWD in generating evidence alongside clinical trials. 

RWD as an easy way to investigate further: The project’s initial results led to a strong interest to perform a more in-depth analysis of a specific subgroup of patients. AstraZeneca obtained approval from the non-WMO Advisory Committee to extend the RWD project to answer the additional questions surrounding this patient group.  

While the outcomes of this extended analysis are pending, the approval to investigate further underscores the importance and potential of RWD studies for extending the scope of studies with new research questions. 

1 Connolly SJ et al. N Engl J Med. 2024;390:1745-1755

LOGEX’s distinctive approach to RWE projects lies in the trusted relationships we have built with hospitals, enabling a collaborative and dynamic data-sharing process. Unlike traditional static datasets, the real-world data used in this project comes from an ongoing continuum, ensuring depth and consistency in the analysis. This trust-based model also allows LOGEX to return to participating hospitals to request additional data points as new research questions arise. As a result, the project retains coherence, with all data originating from the same sources and maintaining alignment with the original dataset. This unique methodology underscores LOGEX’s ability to deliver flexible, reliable, and comprehensive insights for its partners. 

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