In real-world evidence (RWE) research, misclassification is a persistent methodological challenge, particularly when diagnostic information is incomplete, coded inconsistently, ambiguously recorded or entirely absent. When working with data from secondary data sources such as administrative claims or electronic health records (EHRs), not every condition of interest is captured cleanly (or at all) through a well-defined… Continue reading When the Code Isn’t Enough: Building Diagnostic Algorithms and Proxies in RWD Research
Tag: Methodology
Can Real-World Data Redefine Clinical Trial Protocol Design?
A System Built Backwards? Clinical trials are the gold standard for evaluating new treatments, but they are often built on idealized assumptions that poorly reflect the complexity of real-world clinical care. Protocols are crafted around rigid eligibility criteria, theoretical endpoints, and often over-optimized designs that filter out the majority of patients seen in actual clinical… Continue reading Can Real-World Data Redefine Clinical Trial Protocol Design?
What Is Patient-Level Prediction? Personalizing Risk with Real-World Data
With the growing adoption of personalized medicine and the increasing availability of large-scale healthcare data, the ability to anticipate clinical outcomes at the individual patient level is becoming a fundamental component of modern medical decision-making. Healthcare systems, payers, and researchers are seeking ways to move beyond generalized treatment guidelines and toward tailored, data-driven approaches. … Continue reading What Is Patient-Level Prediction? Personalizing Risk with Real-World Data
Label Expansion and the Role of RWD
In the lifecycle of a pharmaceutical product, initial regulatory approval is often just the beginning. A newly authorized drug typically enters the market with a carefully defined label specifying the disease, population, dose, and setting for its use based on data from randomized controlled trials (RCTs). But often label specifications evolve. Real world clinical needs… Continue reading Label Expansion and the Role of RWD
Methodological Challenges in RWE Research in Pediatrics
In the evolving landscape of evidence generation, Real-World Data (RWD) has emerged as a vital source of insights across the product lifecycle. However, when it comes to pediatric populations, the generation of Real-World Evidence (RWE) has its unique challenges, both scientific and structural. Children are not just “small adults”; they represent a highly heterogeneous group… Continue reading Methodological Challenges in RWE Research in Pediatrics