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
Tag: Clinical Trials
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
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
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… Continue reading Innovative study design in clinical research