Millar Andrew W, Lynch Kevin P
The Lawns, Winterbrook Lane, Wallingford, Oxford OX10 9EF, UK.
Nat Rev Cancer. 2003 Jul;3(7):540-5. doi: 10.1038/nrc1124.
The failure of many cytostatic agents in Phase III clinical trials for treatment of common cancers has led researchers to question current approaches to trial development. Recent studies offer some clues as to what is wrong with two particular aspects of clinical trial design--survival as an end point and simultaneous combination with cytotoxic chemotherapy--and indicate possible alternatives.
许多细胞抑制剂在治疗常见癌症的III期临床试验中失败,这使得研究人员质疑当前的试验开发方法。近期研究为临床试验设计的两个特定方面——将生存率作为终点以及与细胞毒性化疗同时联合使用——存在的问题提供了一些线索,并指出了可能的替代方案。