Vollmar Horst Christian, Georgieff Peter, Bührlen Bernhard
Fraunhofer Institut für System- und Innovationsforschung (ISI), Karlsruhe; Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), Standort Witten.
Z Evid Fortbild Qual Gesundhwes. 2010;104(10):738-43. doi: 10.1016/j.zefq.2010.10.001. Epub 2010 Nov 4.
Clinical research is a central link in the development chain of new treatment methods; scientifically, it belongs between basic science and health services research. It spans from the first application of a new substance or device in humans to the main proofs of its efficacy and safety. Economically speaking, it absorbs almost half of the total expenditures for the research and development of a new drug and represents a significant factor in the labour market for researchers and study personnel. Also, through participation in clinical trials, patients gain early access to new treatment methods, while on the other hand they are placed at higher risk for undesired side effects. Politics have taken significant steps to strengthen clinical research, but the pharmaceutical industry continues to complain about competitive disadvantages. Despite internationally recognised and, to a large extent, legally codified guidelines there are still significant national differences in implementation. In addition, traditional practices in clinical research are challenged by novel, mainly biotechnological therapeutic methods for which our current knowledge base is rather limited and which therefore entail a higher risk for patients or trial participants. The following paper summarises a report for the Office of Technology Assessment at the German Federal Parliament (TAB). Based on current regulations, scientific literature and expert interviews, current challenges and solution strategies for clinical research will be analysed in terms of an international comparison.
临床研究是新治疗方法开发链条中的核心环节；从科学角度来看，它介于基础科学与卫生服务研究之间。其涵盖了新物质或新设备在人体中的首次应用，直至其疗效和安全性的主要验证。从经济角度而言，它几乎占新药研发总支出的一半，并且是研究人员和研究人员劳动力市场中的一个重要因素。此外，通过参与临床试验，患者能够较早接触到新的治疗方法，但另一方面，他们面临出现不良副作用的更高风险。政界已采取重大举措来加强临床研究，但制药行业仍抱怨存在竞争劣势。尽管有国际认可且在很大程度上已编入法律的指导方针，但在实施方面仍存在显著的国家差异。此外，临床研究的传统做法受到新型（主要是生物技术）治疗方法的挑战，我们目前对这些方法的知识基础相当有限，因此给患者或试验参与者带来了更高风险。以下论文总结了一份提交给德国联邦议会技术评估办公室（TAB）的报告。基于现行法规、科学文献和专家访谈，将通过国际比较分析临床研究当前面临的挑战和解决策略。
