The Use of Real-World Evidence to Support Regulatory and Reimbursement Decisions

传统上，药物在广泛使用之前要在临床试验中进行广泛研究。最近，一些药物在没有关于其益处和风险的完整数据的情况下被允许进入市场。这意味着这些问题只有在药物上市并用于常规临床实践后才能进行研究；这被称为真实世界的证据。这项研究评估这些证据是否足以证明一种药物是安全有效的

Traditionally, medicines are studied extensively in clinical trials before they are widely available. More recently, some medicines have been allowed to enter the market without complete data on their benefits and risks. This means that these issues can only be studied once a medicine is on the market and used in routine clinical practice; this is referred to as real-world evidence. This research evaluates if this evidence is sufficient to prove that a medicine is safe and that it works