Kölch M, Märsch C, Fegert J M, Lippert H-D
Klinik für Kinder- und Jugendpsychiatrie/Psychotherapie, Ulm.
Gesundheitswesen. 2009 Mar;71(3):127-33. doi: 10.1055/s-0028-1103279. Epub 2009 Feb 16.
The availability of licensed medication for children and adolescents depends on the frequency of clinical trials within this age group. In Germany legislation the framework for clinical trials was changed essentially in 2004 by the 12th amendment on the German Drug Code (AMG). This paper studies the changes in applications to the IRBs for clinical trials in adults and minors before and after implementation of the 12th amendment.
In total four IRB were included in the study. All IRB were located in one German state, all were located at universities or medical schools. Two of the universities have a clinical research unit (CRU) funded by the German Ministry of Research, one of these CRUs has additionally a unit specialised on conducting trials with minors (PadNET). All data were assessed by the applications to the IRB between 2002 and 2006 and analysed by the number of applications, inclusion criteria (with minors or without) and the funding status (investigator initiated trials=IIT or funded by industry).
The total number of applications was stable over the observation period (2002: 1192; 2006: 1231). The number of applications according German Drug Code showed no essential changes (2002: 484; 2006: 504). The number of applications for trials which included minors was low and remained on this low level (2002: 41; 2006: 28). Immediately before and after implementation of the amendment the number of applications increased or, respectively, decreased. IIT with minors constituted a higher proportion of all clinical trials with minors, but in total the number of IIT with minors was low.
The 12th amendment to the German Drug Code had only slight effects on the number of clinical trials in general and especially on the number of clinical trials with minors. Overall, clinical trial with minors make only a small proportion of all applications for clinical trials to the IRB in Germany. The EU regulation on medical products for children may cause an increasing number of clinical trials with minors in the future.
儿童和青少年获得获批药物的情况取决于该年龄组内临床试验的开展频率。在德国法律中，临床试验的框架于2004年随着《德国药品法典》（AMG）的第12次修订而发生了重大变化。本文研究了第12次修订实施前后向独立伦理委员会（IRB）提交的成人和未成年人临床试验申请的变化情况。
该研究共纳入了四个独立伦理委员会。所有独立伦理委员会均位于德国的一个州，且都设在大学或医学院。其中两所大学设有由德国研究部资助的临床研究单位（CRU），其中一个临床研究单位还设有专门从事未成年人试验的部门（PadNET）。所有数据均通过2002年至2006年间向独立伦理委员会提交的申请进行评估，并按申请数量、纳入标准（有未成年人或无未成年人）以及资助状况（研究者发起的试验=IIT或由行业资助）进行分析。
在观察期内申请总数保持稳定（2002年：1192项；2006年：1231项）。根据《德国药品法典》的申请数量没有实质性变化（2002年：484项；2006年：504项）。包含未成年人的试验申请数量较低且维持在该低水平（2002年：41项；2006年：28项）。修订实施前后申请数量分别出现了增加或减少。有未成年人参与的研究者发起的试验在所有有未成年人参与的临床试验中占比更高，但总体而言有未成年人参与的研究者发起的试验数量较少。
《德国药品法典》的第12次修订对一般临床试验数量，尤其是对有未成年人参与的临床试验数量影响甚微。总体而言，在德国向独立伦理委员会提交的所有临床试验申请中，有未成年人参与的临床试验仅占一小部分。欧盟关于儿童医疗产品的法规可能会导致未来有未成年人参与的临床试验数量增加。
