Slone D, Shapiro S, Miettinen O S, Finkle W D, Stolley P D
Ann Intern Med. 1979 Feb;90(2):257-61. doi: 10.7326/0003-4819-90-2-257.
After marketing, drugs should be evaluated for safety and for efficacy. Present national systems are inadequate for both tasks. Safety can be evaluated by means of nonexperimental research, whereas evaluation of efficacy in a variety of settings representing normal medical practice generally requires experiments, randomized and blinded. Research into safety requires the maintenance of routine, yet flexible, multipurpose data systems, different for established and newly marketed drugs. Ad hoc studies on safety and on efficacy can be mounted more swiftly and economically through the maintenance of "standby" capabilities, in addition to maximal use of resources outside the actual national system.
药品上市后，应评估其安全性和有效性。目前的国家体系在这两项任务上都存在不足。安全性可通过非实验性研究进行评估，而在代表正常医疗实践的各种环境中评估有效性通常需要进行随机、双盲实验。安全性研究需要维护常规但灵活的多用途数据系统，针对已上市药品和新上市药品有所不同。除了最大限度地利用实际国家体系之外的资源，通过维持“备用”能力，可以更迅速、更经济地开展关于安全性和有效性的专项研究。
