The growing acceptance of real-world data (RWD) and real-world evidence (RWE) has expanded the horizon for how we generate insights to support decision-making across the product lifecycle. However, while the value of RWD is increasingly recognized by regulators, payers, and safety bodies, the design and methodological rigor of these studies must be carefully tailored to… Continue reading Methodological Considerations in RWD Studies by Intended Use
Tag: Real World Evidence
Bridging Gaps in Oncology RWE: Key Challenges and Practical Solutions
The growing use of real-world data (RWD) in oncology is essential to complement the limitations of clinical trials, which often involve narrowly selected patient populations under specific conditions. In contrast, RWD captures how cancer care is delivered in routine practice across diverse demographics, comorbidities, and healthcare systems. This is particularly critical in oncology, where treatment… Continue reading Bridging Gaps in Oncology RWE: Key Challenges and Practical Solutions
Real World Data and the Unequal Distribution of Evidence Across Therapeutic Areas
The increasing reliance on Real World Data (RWD) to generate Real-World Evidence (RWE) is transforming clinical research, regulatory decision-making, and treatment approval pathways. However, the utility of RWD can vary depending on the therapeutic area. While some fields, such as cardiovascular diseases and diabetes, benefit from structured and routinely collected data, other areas such as… Continue reading Real World Data and the Unequal Distribution of Evidence Across Therapeutic Areas
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?