Secondary and Primary Data Integration in Clinical Research

Secondary data are data that have been originally collected for purposes other than a specific research question. This includes data from sources like electronic medical records (EMRs), medical claims data, product or disease registries, and other digital health technologies. Secondary data are often used in pharmacoepidemiological research to evaluate the safety and effectiveness of medicines… Continue reading Secondary and Primary Data Integration in Clinical Research

EMR to EDC Integration: Applications, Challenges and Operational Considerations

EMR to EDC Integration refers to the process of transferring data from Electronic Medical Records (EMR), which are used in healthcare settings to maintain patient health records, to Electronic Data Capture (EDC) systems, which are specialized databases used in clinical trials to collect and manage study data. This integration aims to automate data transfer, enhancing… Continue reading EMR to EDC Integration: Applications, Challenges and Operational Considerations

Joint Clinical Assessments: Harmonizing Medicine Evaluations Across Europe Under EMA Regulations

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

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