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
Tag: Health Authorities
External Control Arms in Clinical Trials: Case Studies of Health Authority Submissions
In recent years, the landscape of clinical trials has been evolving, with innovative methodologies gaining traction. One of such advancement is the use of External Control Arms (ECAs) in clinical trials. ECAs utilize existing patient data external to the planned clinical trial as a comparison group. An ECA can be constructed using data from… Continue reading External Control Arms in Clinical Trials: Case Studies of Health Authority Submissions