Randomized pragmatic trials for real-world evidence in regulatory decision making: findings from an EFPIA position paper

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a trade association representing the research-based pharmaceutical industry operating in Europe, recently published a position paper outlining their perspectives on the role of randomized pragmatic trials (RPTs) in generating fit-for-purpose real-world evidence (RWE).  “EFPIA is of the opinion that randomized pragmatic trials … may offer the greatest opportunity to generate high-quality RWE to inform regulatory decision making as well as patient and physician treatment decisions in the immediate future.”  Need for RPTs in generating RWE to inform regulatory decision making  Several factors have led to EFPIA assessing the importance of pragmatic...