Two primary methods used to gather data for Real World Evidence (RWE) research are chart reviews and Electronic Medical Record (EMR) extractions. Chart Review involves manually extracting data from patient medical records, including both paper-based charts and digital documents. This method provides a rich source of detailed clinical information. EMR Extractions involve the… Continue reading Chart Review and EMR Extractions in RWE Research
Tag: Real World Evidence
Process for Health Technology Assessments (HTAs) in Germany
Health Technology Assessments (HTAs) in Germany are essential to evaluating the benefits, risks, and economic implications of medical technologies and interventions. The process involves several key institutions. These bodies have distinct roles in evaluating and deciding on the inclusion and reimbursement of health technologies within the healthcare system. Before looking at the process, let’s explore… Continue reading Process for Health Technology Assessments (HTAs) in Germany
Exploring Emulated Clinical Trials: Bridging the Gap Between RCTs and Real-World Evidence
Randomized clinical trials (RCTs) represent the most rigorous and robust research method for determining whether a cause–effect relation exists between an intervention and an outcome. However, RCTs are costly, slow, and often impractical to generate evidence for many important research questions. In the evolving landscape of healthcare research, the concept of emulated clinical trials… Continue reading Exploring Emulated Clinical Trials: Bridging the Gap Between RCTs and Real-World Evidence
Misleading Notions of "Regulatory-Grade" Data in Real-World Evidence Research
The concept of “regulatory-grade” data it has been used to describe data that meets the requirements necessary for regulatory decision-making in real world evidence (RWE) research. This term suggests that the data is of high quality, reliability, and integrity, suitable for supporting regulatory submissions and decisions regarding the safety, efficacy, and quality of medical products.… Continue reading Misleading Notions of "Regulatory-Grade" Data in Real-World Evidence Research
Exploring Social Determinants of Health and Their Significance in Real-World Evidence Research
In public health, the concept of social determinants of health (SDOH) has gained significant attention as a key factor influencing individual and community well-being. Unlike the more traditional focus on medical care and genetic factors, SDOH encompasses the broader socio-economic conditions that affect health outcomes. This post explores the various aspects of SDOH, their impact,… Continue reading Exploring Social Determinants of Health and Their Significance in Real-World Evidence Research