Real-world data (RWD) refers to health-related data collected from sources such as electronic health records (EHRs), insurance claims, patient registries, and patient-reported outcomes. This data offers invaluable insights that can drive innovation, inform clinical decision-making, and enhance patient care.
To unlock the full potential of RWD, data from different sources needs to be transformed into real-world data products—structured, analysis-ready datasets that are curated, standardized, and quality-controlled for specific research or clinical use cases. These data products enable researchers and clinicians to efficiently generate real-world evidence (RWE)—the clinical evidence regarding the usage and potential benefits or risks of medical products derived from the analysis of RWD.
However, transforming raw RWD into high-quality, analysis-ready data products that meet regulatory standards poses unique challenges. Issues such as data variability, missing information, and privacy concerns must be addressed to ensure the data’s reliability and compliance. In this blog, we will explore these challenges and discuss strategies to effectively create robust RWD products that can support impactful, regulatory-grade real-world evidence.
Suggested reading - What is a RWD?
With this understanding of RWD and RWE, let’s explore how to create compliant, high-impact data products that unlock their full potential.
Data Quality and Standardization RWD come from diverse sources with varying degrees of structure, completeness, and quality. Real-world data products are structured, cleaned, and standardized datasets derived from raw RWD. Data harmonization efforts, such as adopting the Observational Medical Outcomes Partnership (OMOP) Common Data Model, are essential for creating interoperable data products that can drive reliable insights.
Integration of Multi-Modal Data High-impact data products often requires the integration of multi-modal data, including genomic, imaging, and longitudinal clinical data. Achieving seamless integration while maintaining data integrity and compliance requires advanced analytics capabilities and robust infrastructure.
Ensure Regulatory-Grade Data Governance Establish a robust data governance framework to address compliance requirements and ethical considerations. Regular audits, clear accountability structures, and transparent reporting mechanisms are essential for building regulatory-grade data products.
Flatiron Health provides researchers access to high-quality EHR-derived RWD products from the UK, Germany, and Japan.
Problem: Flatiron Health required a secure solution to provide access to RWD products.
Solution: To facilitate access and analysis of data in situ, Lifebit provides Flatiron Health with a federated Trusted Research Environment (TRE) to securely host anonymized patient-level data in-country, allowing cross-border research while ensuring data never leaves local jurisdictions. Researchers can perform comprehensive analyses across datasets from Japan, Germany, the UK with strict controls to prevent the download of individual-level data. This combination of secure access to distributed, high-quality RWD products is facilitating high-impact research that will drive groundbreaking discoveries in cancer research and care.
RWD offers a powerful tool for advancing healthcare, but its potential can only be realized through well-designed, compliant data products. By addressing the challenges and embracing best practices, Lifebit’s federated TRE enables a future where real-world data can be used to improve decisions, develop more effective treatments, and improve health outcomes for all.
Learn more about how Lifebit’s solutions can accelerate & automate your development of Real World Data products.
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Lifebit is a global leader in precision medicine data and software, empowering organisations across the world to transform how they securely and safely leverage sensitive biomedical data. We are committed to solving the most challenging problems in precision medicine, genomics and healthcare with a mission to create a world where access to biomedical data will never again be an obstacle to curing diseases.