Natural history of disease studies are intended to track the course of a disease by identifying demographic, genetic, environmental, and other variables (e.g., treatments, concomitant medications) that correlate with the disease’s development and outcomes. Natural history of disease studies play a crucial role in integrated evidence generation plans, especially for rare diseases and conditions where… Continue reading Leveraging Natural History of Disease Studies for Integrated Evidence Generation Plans and Regulatory Success
Tag: Clinical Research
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
Chart Review and EMR Extractions in RWE Research
Two primary methods used to gather data for Real World Evidence (RWE) research are chart reviews and Electronic Medical Record (EMR) extractions. Chart Review involves manually extracting data from patient medical records, including both paper-based charts and digital documents. This method provides a rich source of detailed clinical information. EMR Extractions involve the… Continue reading Chart Review and EMR Extractions in RWE Research
Standards of clinical research and reporting
Selecting the appropriate study design is crucial for the effective execution of clinical research. Researchers can choose from a variety of study designs within two main categories: observational and interventional studies. Each design offers unique strengths and weaknesses, and understanding these limitations is essential for drawing accurate conclusions. Observational study designs, also called epidemiological study… Continue reading Standards of clinical research and reporting