DDReg Pharma- Consulting in regulatory affairs and drug safety

The traditional randomized controlled trial (RCT) has long been the gold standard for evaluating the efficacy and safety of medical interventions. However, its inherent rigidity, limited generalizability, and operational burden have raised questions about its efficiency in today’s rapidly evolving healthcare landscape. In response, the   U.S. Food and Drug Administration (FDA)   launched FDA’s Project Pragmatica, a pioneering initiative aimed at advancing Embedded Pragmatic Clinical Trials (ePCTs) to transform the future of regulatory-grade evidence generation. Project Pragmatica signals a strategic pivot in regulatory science, one that embraces real-world settings, patient-centered methodologies, and clinical trial simplification without compromising data integrity or scientific rigor. What Are Embedded Pragmatic Clinical Trials (ePCTs)? Unlike explanatory trials, which are tightly controlled and focus on efficacy under ideal conditions,  pragmatic trials  are desig...