The growing acceptance of real-world data (RWD) and real-world evidence (RWE) has expanded the horizon for how we generate insights to support decision-making across the product lifecycle. However, while the value of RWD is increasingly recognized by regulators, payers, and safety bodies, the design and methodological rigor of these studies must be carefully tailored to… Continue reading Methodological Considerations in RWD Studies by Intended Use
Tag: Methodology
Bridging Gaps in Oncology RWE: Key Challenges and Practical Solutions
The growing use of real-world data (RWD) in oncology is essential to complement the limitations of clinical trials, which often involve narrowly selected patient populations under specific conditions. In contrast, RWD captures how cancer care is delivered in routine practice across diverse demographics, comorbidities, and healthcare systems. This is particularly critical in oncology, where treatment… Continue reading Bridging Gaps in Oncology RWE: Key Challenges and Practical Solutions
Digital Biomarkers: Transforming Healthcare Through Continuous and Real-World Monitoring
Digital biomarkers are revolutionizing the way healthcare professionals and researchers monitor, diagnose, and treat diseases. Enabled by digital technologies, these biomarkers provide objective, quantifiable physiological and behavioral data collected through connected devices such as smartphones, wearables, and sensors. Unlike traditional biomarkers, which rely on laboratory tests or imaging, digital biomarkers enable continuous, real-world monitoring, offering… Continue reading Digital Biomarkers: Transforming Healthcare Through Continuous and Real-World Monitoring
Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations
Post-Authorization Safety Studies (PASS) are vital tools for monitoring the safety of medicines after they have been approved for use in the general population. In the European Union (EU), these studies are conducted within the framework established by the European Medicines Agency (EMA). However, when conducting a PASS under the EMA framework, there might be… Continue reading Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations
HealthData@EU: Cross-Border Healthcare Data Sharing in Europe
With the evolving data-driven innovation, the ability to securely share health information across borders has become important for advancing medical research, improving patient care, and supporting public health initiatives. The European Union has taken a significant step forward with HealthData@EU, an innovative initiative aimed at creating a unified framework for cross-border healthcare data sharing. … Continue reading HealthData@EU: Cross-Border Healthcare Data Sharing in Europe