McLemore Monica R
Department of Physiologic Nursing, School of Nursing, University of California, San Francisco, USA.
Clin J Oncol Nurs. 2006 Apr;10(2):153-4. doi: 10.1188/06.CJON.153-154.
In early February 2006, Genentech Inc. issued a joint press release with Roche Holding Corporation explaining that their phase III early-stage colon cancer trial of Avastin (bevacizumab, Genentech Inc., South San Francisco, CA) would be stopped after the deaths of four patients. This announcement was the result of preliminary review of the data by the Data Safety Monitoring Board (DSMB) that was formed to monitor the study. What is the DSMB? What criteria does it use to determine whether a study should be stopped early? The purpose of this article is to (a) explain the role of the DSMB, (b) give an overview of the Avastin Adjuvant (AVANT) study, and (c) provide information and resources about clinical trials for practicing RNs in oncology.
2006年2月初，基因泰克公司与罗氏控股公司联合发布了一份新闻稿，解释称其针对阿瓦斯汀（贝伐单抗，基因泰克公司，加利福尼亚州南旧金山）的III期早期结肠癌试验将在4名患者死亡后停止。这一宣布是由为监测该研究而成立的数据安全监测委员会（DSMB）对数据进行初步审查的结果。什么是数据安全监测委员会？它使用什么标准来确定一项研究是否应提前终止？本文的目的是（a）解释数据安全监测委员会的作用，（b）概述阿瓦斯汀辅助治疗（AVANT）研究，以及（c）为肿瘤学领域执业的注册护士提供有关临床试验的信息和资源。
