随机试验的中期分析改变肿瘤学实践：辅助曲妥珠单抗和 HERA 试验的教训。
When an interim analysis of randomized trial changes the practice in oncology: the lesson of adjuvant Trastuzumab and the HERA trial.
机构信息
Operative Unit Medical Oncology 2, Instituto Oncologi Veneto IRCCS, Via Gattamelata 64, 35128 Padua, Italy.
出版信息
Immunopharmacol Immunotoxicol. 2009 Mar;31(1):30-1. doi: 10.1080/08923970802340332.
PMID:21054206
Abstract
About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.
摘要
约 30%的随机临床试验因明显的临床获益而提前终止。虽然中期分析可保护处于治疗组间显著不均衡风险下的患者，但由此得出的结论可能不成熟，应谨慎看待。我们报告了从曲妥珠单抗辅助治疗（HERA）试验中吸取的经验教训。
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