In Endurance Sports, Nutrition Is Not Advice, It’s an Intervention From Endurance Sport to Precision Nutrition Not many people who know me as a Real World Data professional in pharma are aware that I also run a side activity in precision nutrition for endurance athletes. This work began naturally, driven by my personal… Continue reading Using Real-World Data to Drive Precision Nutrition for Endurance Athletes
Category: Data
Operational Challenges of Conducting RWD Studies in China
by Monique Samuels The use of real-world data (RWD) is growing across the industry and is increasingly encouraged by regulatory agencies worldwide. RWD can provide insights into patient populations, treatment patterns, and outcomes outside of controlled clinical trials. China, with its large and diverse patient population, offers an important opportunity for global evidence… Continue reading Operational Challenges of Conducting RWD Studies in China
Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The approval of eflornithine (brand name Iwilfin) for pediatric high-risk neuroblastoma offers an interesting example of how the FDA evaluates single-arm trials supported by external control arms (ECAs). External controls are increasingly common in oncology and rare disease drug development, but they remain a source of careful regulatory scrutiny. In this case, the FDA’s assessment… Continue reading Regulatory Insights from FDA Review of the External Control Arm in a Pediatric Rare Disease Trial
The Expanding Role of Epidemiology in Modern Real-World Data Research
When observational retrospective research began to be used more systematically more than twenty years ago, the real-world data (RWD) landscape was relatively simpler. Not necessarily easier, but simpler. A limited number of large administrative and clinical databases dominated the field. Claims databases, national registries and a handful of electronic medical record (EMR) sources were directing… Continue reading The Expanding Role of Epidemiology in Modern Real-World Data Research
The Hidden Architecture of RWE: When Complete Data Stop Being True Data
Real-world evidence (RWE) is built on the premise that data generated during routine clinical care can reveal how medicines and interventions actually perform outside the environment of controlled trials. Electronic health records (EHRs) and disease registries are often treated as the foundational infrastructure of this approach. To improve data quality, many systems increasingly rely on… Continue reading The Hidden Architecture of RWE: When Complete Data Stop Being True Data