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
Author: Nadia Barozzi
Passionate about data-driven insights and the advancement of Real World Evidence research, drug safety and pharmacovigilance.
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
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
Understanding Fit-for-Purpose in Real-World Data Research
Fit-for-purpose refers to data that is appropriately suited to meet the specific objectives and requirements of a research study. It emphasizes the need for data to be not only available but also relevant, reliable, and capable of answering the research questions accurately and efficiently. Key Characteristics of Fit-for-Purpose Data 1. Relevance: The data must be… Continue reading Understanding Fit-for-Purpose in Real-World Data Research
Common Data Models in Clinical Research
In clinical research, data models are essential for organizing, storing, and analyzing complex healthcare data. Effective data modeling ensures accurate data integration, facilitates efficient data analysis, and enhances data sharing across different systems and studies. Let’s explore some of the most commonly used data models in clinical research and their applications. 1. CDISC… Continue reading Common Data Models in Clinical Research