The increasing reliance on Real World Data (RWD) to generate Real-World Evidence (RWE) is transforming clinical research, regulatory decision-making, and treatment approval pathways. However, the utility of RWD can vary depending on the therapeutic area. While some fields, such as cardiovascular diseases and diabetes, benefit from structured and routinely collected data, other areas such as… Continue reading Real World Data and the Unequal Distribution of Evidence Across Therapeutic Areas
Category: Methodology
Challenges in Conducting RWE Research in Lifestyle-Driven Therapeutic Areas
Real-world evidence (RWE) research plays a critical role in understanding disease progression, treatment effectiveness, and patient outcomes outside of controlled clinical trial settings. However, in therapeutic areas where lifestyle and behavioral factors significantly influence disease onset and progression, such as metabolic disorders, cardiovascular diseases, and mental health conditions – RWE studies face unique challenges. A… Continue reading Challenges in Conducting RWE Research in Lifestyle-Driven Therapeutic Areas
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
Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
What is Transportability in RWE?Transportability in Real-World Evidence (RWE) research refers to the ability to extend findings from one study population to a different, but related, population. This concept is critical when evaluating whether treatment effects observed in one geographical region, healthcare system, or patient cohort could be generalized to another population with different demographic,… Continue reading Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations