Chvetzoff G, Ray-Coquard I, Dumortier A, Engel C, Mevelec M F, Latour J F, Philip T, Chauvin F
Département de cancérologie médicale, Centre Léon-Bérard, 28, rue Laennec, 69373 Lyon Cedex 08.
Bull Cancer. 2000 Sep;87(9):671-9.
Clinical research is one of the main activities in cancer centres and is submitted in France to a specific law (named "loi Huriet") which includes good clinical practices. We are now conducting a general program of quality evaluation and improvement in the regional cancer centre of Lyon (centre Léon-Bérard). Part of this program is an audit of the application of the Huriet law. Since no instrument exist for measuring this application, we have created a specific one, that attribute notation according to the different aspects of the law. Results show a good level of conformity but sometime non sufficient. There is no difference between the two studied years. Quality changes according to promoters (private or academic) and monitoring. Written procedures and specific training for the different actors are required to improve quality of clinical research with focus on the patient interest.
临床研究是癌症中心的主要活动之一，在法国需遵循一项包含良好临床实践的特定法律（即“于里埃法”）。我们目前正在里昂地区癌症中心（莱昂 - 贝拉尔中心）开展一项全面的质量评估与改进计划。该计划的一部分是对“于里埃法”的实施情况进行审核。由于尚无衡量该法律实施情况的工具，我们创建了一个专门的工具，它会根据法律的不同方面进行评分。结果显示整体符合程度良好，但有时也存在不足。在研究的这两年间没有差异。质量因发起者（私立或学术机构）以及监管情况而异。需要为不同参与者制定书面程序并提供特定培训，以提高临床研究质量，重点关注患者利益。
