Considerations for using Real-World Evidence in regulatory and reimbursement decision-making

Le résumé fourni par la source

In recent years, the role of real-world evidence (RWE) in regulatory decision-making has gained significant attention due to the growing availability of real-world data (RWD) and the limitations of randomized controlled trials (RCTs). While RCTs remain the gold standard for evaluating the safety and efficacy of new medicines, they are often costly, time-consuming, and may lack generalizability to broader patient populations. As a result, regulatory agencies are increasingly looking to RWE as a complementary source of evidence that can provide insights into the use, safety, and effectiveness of medicines in real-world settings.

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