A Joint Clinical Assessment (JCA) refers to a coordinated evaluation of the clinical evidence of a medicine’s efficacy, safety, and therapeutic value, conducted by multiple health technology assessment (HTA) bodies across Europe. This process aims to streamline and harmonize the assessment procedures, ensuring that all participating countries have access to consistent and high-quality clinical evaluations.… Continue reading Joint Clinical Assessments: Harmonizing Medicine Evaluations Across Europe Under EMA Regulations
Author: Nadia Barozzi
Passionate about data-driven insights and the advancement of Real World Evidence research, drug safety and pharmacovigilance.
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
Challenges in Assessing Drug Exposure in Drug Utilization Studies
Drug utilization studies (DUS) using real-world data (RWD) are essential for understanding how medications are prescribed, dispensed, and used in everyday clinical practice. Unlike clinical trials, which are conducted under controlled conditions, RWD is derived from routine healthcare settings, including electronic health records (EHRs), insurance claims, patient registries, and pharmacy data. These studies provide… Continue reading Challenges in Assessing Drug Exposure in Drug Utilization Studies
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