癌症化疗研发中的试验管理
Management of trials in the development of cancer chemotherapy.
作者信息
Williams C J, Carter S K
出版信息
Br J Cancer. 1978 Mar;37(3):434-47. doi: 10.1038/bjc.1978.64.
Abstract
Potential anti-cancer agents have classically undergone clinical assessment in Phase I, II and III trials. This paper examines the role of these trials and pre-clinical studies in the light of improving cancer chemotherapy. Many patients must now be treated with standard therapy before investigational drugs can be ethically used. The introduction of combined modality trials will require a very prolonged follow-up to demonstrate improved survival and recognize late onset of chronic toxicity.
摘要
潜在的抗癌药物传统上要经过I期、II期和III期临床试验的评估。本文根据改进癌症化疗的情况，审视了这些试验和临床前研究的作用。现在，在符合伦理地使用研究性药物之前，许多患者必须先接受标准治疗。联合治疗试验的引入将需要很长时间的随访，以证明生存率有所提高，并识别慢性毒性的迟发情况。
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