Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (Inserm), Paris, France.
Trials. 2009 Oct 16;10:95. doi: 10.1186/1745-6215-10-95.
Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.
In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey.
The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising.
The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
由于欧盟成员国在监管和认知方面的复杂性和异质性，透彻了解监管要求是在欧洲进行多国临床研究的一项具有挑战性的先决条件。
为了总结与广泛的临床研究相关的现状，欧洲临床研究基础设施网络（ECRIN）在十个欧洲国家进行了一项多国调查。然而，调查发现缺乏主要类别的临床研究的通用分类框架，因此就共同的分类达成一致意见是制定调查的初始步骤。
由来自十个欧洲国家的临床研究领域专家组成的 ECRIN 监管跨国工作组定义了七个主要类别的临床研究，从监管和科学的角度来看，这些研究似乎是相关的，并且在所有国家都有一致的定义：药物临床试验；医疗器械临床试验；其他治疗试验（包括手术试验、移植试验、输血试验、细胞治疗试验等）；诊断研究；营养临床研究；其他介入性临床研究（包括补充和替代医学试验、血液或组织样本采集试验、生理学研究等）；以及流行病学研究。我们的分类对于开发一项侧重于向伦理委员会和主管当局提交方案、修正案程序、赞助商和保险要求以及不良事件报告的调查至关重要，调查涵盖五个主要阶段：起草、共识、数据收集、验证和最终确定。
调查中使用的临床研究类别列表可以为欧洲临床研究监管要求的协调和简化这一迫切需要的任务做出贡献。
