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: EMR
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
The Evolving Integration of NGS Data into EMRs: Transforming Clinical Research and Precision Medicine
Next-Generation Sequencing (NGS) is a technology that allows the rapid sequencing of entire genomes, targeted regions, or specific sets of genes. It represents a significant advancement that enables the parallel sequencing of millions of DNA fragments simultaneously. NGS can be used for a variety of applications, including whole-genome sequencing (WGS), whole-exome sequencing (WES), targeted gene… Continue reading The Evolving Integration of NGS Data into EMRs: Transforming Clinical Research and Precision Medicine
RWD for EMA Regulatory Submissions: Differences in Use for Pre- vs. Post-Approval
Real‐world evidence (RWE) has an increasing role in both pre-, and post- approval applications to support the authorization of new medicines and indications, or to address post-marketing safety concerns. Therefore, the use of Real-World Data (RWD) in regulatory processes at the European Medicines Agency (EMA) varies depending on whether it is being used for… Continue reading RWD for EMA Regulatory Submissions: Differences in Use for Pre- vs. Post-Approval
Secondary and Primary Data Integration in Clinical Research
Secondary data are data that have been originally collected for purposes other than a specific research question. This includes data from sources like electronic medical records (EMRs), medical claims data, product or disease registries, and other digital health technologies. Secondary data are often used in pharmacoepidemiological research to evaluate the safety and effectiveness of medicines… Continue reading Secondary and Primary Data Integration in Clinical Research