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
Category: Real World Evidence
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
Innovative study design in clinical research
Clinical trials bridge the gap between preclinical studies and marketed products, with a primary goal of determining safety and efficacy. Over the years, clinical trial protocols have significantly developed in term of design and execution. Innovation in clinical trials design has resulted in the increase of the adoption of innovative design types such as adaptive,… Continue reading Innovative study design in clinical research