by Mathieu Ghadanfar, MD, FESC, FAHA Cardiovascular medicine has entered an era of extraordinary randomized evidence. DAPA-HF, EMPEROR-Reduced, EMPA-KIDNEY, the SELECT trial (1, 2, 3): each enrolling tens of thousands of patients, each reshaping guidelines. And yet the questions that dominate daily clinical decision-making remain unanswered by any of them. No large randomized… Continue reading When the Real World Emerges from the Trial Shadow: Cardiovascular RWE at an Inflection Point
Category: Methodology
Do We Still Need Country-Specific Data?
In the European Union, data on racial or ethnic origin are classified as a “special category” under Article 9 of the GDPR, which generally prohibits their processing unless specific conditions are met, such as explicit consent or substantial public interest safeguards. As a result, several EU countries, including France, Germany, Denmark, and Sweden, do not… Continue reading Do We Still Need Country-Specific Data?
Real-World Evidence Without Data Ownership: How CROs Compete on Execution
The growing role of real-world evidence (RWE) across research, development, and decision-making has provided new opportunities for contract research organizations (CROs) operating in this space. However, the market of CROs delivering RWE is structurally unequal. With the notable exception organizations with proprietary data assets such as IQVIA, most CROs do not own large-scale proprietary healthcare… Continue reading Real-World Evidence Without Data Ownership: How CROs Compete on Execution
Using Real-World Data to Drive Precision Nutrition for Endurance Athletes
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
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