Background: A significant number of clinical trials must be prematurely discontinued due to recruitment failure, and only a small fraction publish results and a failure analysis. Based on our experience on conducting the NEOPA trial on neoadjuvant radiochemotherapy for resectable and borderline resectable pancreatic carcinoma (NCT01900327—funded by the German Federal Ministry of Education and Research—BMBF), we performed an analysis of potential reasons for recruitment failure and general problems in conducting clinical trials in Germany. Methods: Systematic analysis of environmental factors, trial history, conducting and funding in the background of the published literature. Results: The recruitment failure was based on various study-specific conceptional and local environmental aspects and in peculiarities of the German surgical study culture. General reservations against a neo-adjuvant study concept combined with game changing scientific progresses during the long-lasting planning and funding phase have led to a reduced interest in the trial design and recruitment. Conclusions: Trial planning and conducting should be focused, professionalized and financed on a national basis. Individual interests must be subordinated to reach the goal to perform more relevant and successful clinical trials in Germany. Bureaucratic processes must be further fastened between a trial idea and the start of a study.
背景：大量临床试验因招募失败而被迫提前终止，其中仅有一小部分会公布结果并进行失败原因分析。基于我们在开展NEOPA试验（针对可切除及临界可切除胰腺癌的新辅助放化疗研究，项目编号NCT01900327，由德国联邦教育与研究部资助）过程中积累的经验，本研究系统分析了德国临床试验中招募失败的可能原因及普遍存在的实施难题。方法：结合已发表文献，系统分析试验环境因素、研究历史背景、实施过程及资助机制。结果：招募失败源于多方面因素，包括研究方案设计缺陷、地域环境限制，以及德国外科研究文化的特殊性。对新辅助治疗方案的普遍质疑，加之漫长筹备与资助期间出现的颠覆性科研进展，共同导致研究者对该试验方案兴趣减退、招募意愿降低。结论：临床试验的规划与实施应在国家层面实现专业化聚焦与资金统筹。为在德国开展更多具有临床价值且成功的试验，必须将个体利益服从于整体目标。同时需大幅压缩从试验构想到研究启动之间的官僚审批流程。
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