Vos E J, Huitema A D R
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis, Amsterdam.
Ned Tijdschr Geneeskd. 2006 Sep 23;150(38):2104-7.
The revised Dutch Medical Research in Human Subjects Act (WMO), which implements the European directive regarding 'good clinical practice in the conduct of clinical trials on medicinal products for human use' (2001/20/EC), became effective on March 1, 2006. The revision places additional requirements on trials of medicinal products. Whether a trial should be regarded as a trial of a medicinal product is therefore an important question. The law does not provide adequate guidance for the classification of trials in which biological samples are collected, e.g. for genomic, proteomic or pharmacokinetic studies, while a medicinal product is given for a registered indication. Classifying these types of trials as trials of medicinal products does not enhance the safety of the participants. Therefore, these studies should not be considered as trials of medicinal products to avoid the increased administrative burden required by the revised WMO.
经修订的荷兰《人体医学研究法》（WMO）实施了关于“人用药品临床试验的良好临床实践”的欧洲指令（2001/20/EC），于2006年3月1日生效。此次修订对药品试验提出了更多要求。因此，一项试验是否应被视为药品试验是一个重要问题。对于收集生物样本的试验分类，例如用于基因组、蛋白质组或药代动力学研究，同时药品用于已注册适应症的情况，该法律并未提供充分指导。将这些类型的试验归类为药品试验并不能提高参与者的安全性。因此，为避免修订后的WMO所要求的行政负担增加，这些研究不应被视为药品试验。
