Navigating The Evolving Regulatory And Data Landscape

Real-world evidence (RWE) is rapidly transforming the clinical research landscape, emerging as a crucial element in drug development and regulatory decision-making. In a recent LinkedIn Live event, Derk Arts, CEO of Castor, explored this shift with experts Matt Veatch and Aaron Kamauu from Navidence. They discussed how the 21st Century Cures Act and global regulatory bodies like the EMA and China’s NMPA are driving RWE adoption, emphasizing the strategic necessity of developing robust RWE strategies. The discussion highlighted the growing importance of precision in RWE studies, the potential of hybrid models combining RWE with traditional data, and the ethical implications of external control arms in high-need areas like oncology.

As regulatory expectations rise, the conversation underscored the need for innovation and rigor in utilizing real-world data. The future of clinical research belongs to those who can adeptly balance these evolving demands. Watch the full discussion for deeper insights.