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
Tag: RWD
Bridging the Gap: Key Data Elements in Oncology RCTs vs. RWD
Conducting Real-World Evidence (RWE) research in oncology requires access to diverse data sources, such as patient registries, electronic health records (EHR), claims data, and cancer-specific databases. These data sources often vary in completeness and quality limiting their suitability. Additionally, the rapid advancement of cancer therapies, including immunotherapies, targeted therapies, and combination treatments, complicates the ability… Continue reading Bridging the Gap: Key Data Elements in Oncology RCTs vs. RWD
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
To RCT or not to RCT?
While interventional, randomized double blind placebo-controlled studies are the gold standard used to assess efficacy of interventions [1], answering other scientific questions does not necessarily require an active intervention. My point is not to dis experimental studies in any way, as experimental studies are considered to be more reliable than observational studies because the process… Continue reading To RCT or not to RCT?
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