Laboratoire Boehringer Ingelheim, Reims, France.
Therapie. 2010 Jul-Aug;65(4):301-8, 291-9. doi: 10.2515/therapie/2010038. Epub 2010 Sep 21.
The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE). While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive's dispositions could be improved, such as the definition of "investigational medicinal products" (IMP) and what should be considered as "substantial amendements", as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states. Other points in the Directive do require revision, especially those relating to: the definition of the respective roles of Ethics Committees and Competent Authorities, the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report), the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational. The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country's regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as "drug therapy strategy trials", modulating restrictions according to the "risk added by the research" would enable the trial's organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling.
本次圆桌会议旨在就即将修订的欧洲临床试验药物指令（2001/20/CE）提出建议。虽然遵守该指令非常重要，但在欧盟的一些成员国中，执行情况并不理想。进一步简化并协调其在每个国家的应用将具有建设性意义。无需进行修订，就可以改进该指令的某些规定，例如“研究用药品”（IMP）的定义和什么应被视为“实质性修订”，并协调和改进伦理委员会的运作方式，可以在欧盟委员会层面上进行，也可以更多地依靠已经存在于若干欧洲成员国的欧洲研究伦理委员会网络（EUREC）。该指令的其他一些规定确实需要修订，特别是与以下方面有关的规定：伦理委员会和主管当局各自作用的定义、简化向伦理委员会提供的安全性信息（允许其访问 Eudravigilance 数据库以获取临床试验期间发生的不良反应，并仅向其提供新的安全性问题或年度安全性报告摘要）、当试验为多国试验时，试验单一的欧洲授权的可能性，集中化和/或分散化。建议的变更可以在欧洲法规的范围内进行，避免日后需要将其转译为每个国家的法规，从而避免可能出现的不协调问题。更具体地说，对于具有机构赞助商和/或研究人员驱动的试验（如“药物治疗策略试验”），根据“研究带来的风险”来调节限制，可以简化试验的组织，在监测、不良反应报告和研究药物标签方面。
