Cohen A F
Centre for Human Drug Research, Zernikedreef 10, 2333 CL Leiden.
Ned Tijdschr Geneeskd. 2003 Aug 2;147(31):1493-5.
As of May 2004, the new European directive 2001/20/EC will require European member states to follow Good Clinical Practice rules for non-commercial academic clinical investigations. For several member states this poses a serious threat to such investigations. In the Netherlands however, most items of the new directive can be incorporated in the Dutch Medical Research Involving Human Subjects Act. In fact, many of the items are already covered by this Act, notably with respect to data integrity and patient safety. However, an extra effort is needed to implement the quality control standards to which the registration research already complies. The Dutch Medical Research Involving Human Subjects Act is currently being amended to comply with the new European directive. This is also an ideal opportunity for enhancing the national climate of clinical research and ensuring an improved translation of local research ideas into clinical trial protocols.
截至2004年5月，新的欧洲指令2001/20/EC将要求欧洲成员国遵循非商业性学术临床研究的良好临床实践规则。对几个成员国而言，这对这类研究构成了严重威胁。然而在荷兰，新指令的多数条款可纳入荷兰《涉及人类受试者的医学研究法》。事实上，该法已涵盖了许多条款，尤其是在数据完整性和患者安全方面。然而，需要付出额外努力来实施注册研究已经遵守的质量控制标准。荷兰《涉及人类受试者的医学研究法》目前正在修订，以符合新的欧洲指令。这也是改善国家临床研究氛围并确保将本地研究想法更好地转化为临床试验方案的理想契机。
