Johnson J R, Temple R
Cancer Treat Rep. 1985 Oct;69(10):1155-9.
For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and comparative. The use of historical controls, while sometimes acceptable, must be justified. A favorable effect on survival and/or quality of life is generally required for approval. The study of cancer drugs in combination presents problems which are discussed. Drug firms are strongly urged to discuss the protocols with the Food and Drug Administration prior to initiating phase III comparative studies to be used for approval of the drug.
对于新药审批，法律要求每种适应症至少有两项独立的严格对照研究。首选的研究设计是前瞻性、随机化和对比性的。使用历史对照虽然有时可以接受，但必须有正当理由。通常要求对生存和/或生活质量有积极影响才能获批。文中讨论了癌症联合用药研究存在的问题。强烈敦促制药公司在启动用于药物审批的III期对比研究之前，与食品药品监督管理局讨论研究方案。
