1. BackgroundEpidemiology studies the causes and consequences of morbidity and mortality across geographical boundaries, with emphasis on equitable disease control and health promotion in low-income and middle-income countries [1]. During the past decade, research integrity and research fairness have gained considerable momentum as they have direct implications for global health epidemiology [1]. Research integrity has emerged… Continue reading Fragmented Foundations: Why GEP Needs Global Standards Now
Category: Epidemiology
Challenges in Conducting RWE Research in Lifestyle-Driven Therapeutic Areas
Real-world evidence (RWE) research plays a critical role in understanding disease progression, treatment effectiveness, and patient outcomes outside of controlled clinical trial settings. However, in therapeutic areas where lifestyle and behavioral factors significantly influence disease onset and progression, such as metabolic disorders, cardiovascular diseases, and mental health conditions – RWE studies face unique challenges. A… Continue reading Challenges in Conducting RWE Research in Lifestyle-Driven Therapeutic Areas
To RCT or not to RCT?
While interventional, randomized double blind placebo-controlled studies are the gold standard used to assess efficacy of interventions [1], answering other scientific questions does not necessarily require an active intervention. My point is not to dis experimental studies in any way, as experimental studies are considered to be more reliable than observational studies because the process… Continue reading To RCT or not to RCT?
Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
What is Transportability in RWE?Transportability in Real-World Evidence (RWE) research refers to the ability to extend findings from one study population to a different, but related, population. This concept is critical when evaluating whether treatment effects observed in one geographical region, healthcare system, or patient cohort could be generalized to another population with different demographic,… Continue reading Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
Challenges in Assessing Drug Exposure in Drug Utilization Studies
Drug utilization studies (DUS) using real-world data (RWD) are essential for understanding how medications are prescribed, dispensed, and used in everyday clinical practice. Unlike clinical trials, which are conducted under controlled conditions, RWD is derived from routine healthcare settings, including electronic health records (EHRs), insurance claims, patient registries, and pharmacy data. These studies provide… Continue reading Challenges in Assessing Drug Exposure in Drug Utilization Studies