The Expanding Role of Real-World Evidence Trials in Health CareDecision Making

摘要

Real-world evidence (RWE) is the clinical evidence about benefits or risks ofmedical products derived from analyzing real world data (RWD), which are datacollected through routine clinical practice. This article discusses theadvantages and disadvantages of RWE studies, how these studies differ fromrandomized controlled trials (RCTs), how to overcome barriers to currentskepticism about RWE, how FDA is using RWE, how to improve the quality of RWE,and finally the future of RWE trials.