Berdel Wolfgang E
Department of Medicine A (Hematology, Hemostaseology, Oncology, Pneumology), University Hospital of Muenster, 48149 Muenster, Germany.
Cancers (Basel). 2022 Mar 3;14(5):1308. doi: 10.3390/cancers14051308.
Shortly after the beginning of the year 2000, multiple legal changes with impacts on the regulatory framework of clinical trials became effective almost simultaneously. They included the European Union (EU) Clinical Trial Directive (CTD) 2001/20 followed by major changes in national drug laws, the change in the legal status of German University Hospitals (1998), and a new disease-related groups (DRG)-based reimbursement system for hospitals in Germany (2000). Together, these changes created enormous bureaucratic and financial inhibition of activation and conduct of academic investigator-initiated clinical trials (IIT). Examples for activating clinical trials in oncology before and after 2004 are outlined and discussed, focussing on extended time frames, the establishment of centralized responsibility structures and the exploding financial consequences. In addition, the evolution of trial numbers and the distribution of trial initiators between "commercial" and "academic" over time are discussed together with the occurrence of clinical registries. At the same time, progress in molecular biology led to a plethora of new targets for effective pharmacological therapy of life-threatening diseases such as cancer, and the overall number of clinical trials has not decreased. Yet, judging the regulatory and administrative hurdles between scientific study design and first-patient on trial before and after 2004 and weighing these against the lack of evidence that this regulation has achieved its goal to enhance patient safety and trial quality, the necessity to completely overhaul this CTD becomes obvious. A main goal of such an initiative should be to minimize bureaucracy. For the specific situation in Germany, relocation of responsibility and freedom to operate in University Hospitals and Medical Faculties back to the physician-scientists and reduction in interference by legal divisions should be a goal as well as increasing the public financial support for IITs.
2000年初过后不久，多项对临床试验监管框架产生影响的法律变革几乎同时生效。这些变革包括欧盟（EU）临床试验指令（CTD）2001/20，随后各国药品法律发生重大变化，德国大学医院法律地位的改变（1998年），以及德国医院基于疾病相关分组（DRG）的新报销系统（2000年）。这些变革共同对学术研究者发起的临床试验（IIT）的启动和开展造成了巨大的官僚主义和经济阻碍。本文概述并讨论了2004年前后肿瘤学领域开展临床试验的实例，重点关注延长的时间框架、集中责任结构的建立以及激增的财务后果。此外，还讨论了试验数量的演变以及随着时间推移“商业”和“学术”试验发起者的分布情况，以及临床注册登记的出现。与此同时，分子生物学的进展催生了大量针对癌症等危及生命疾病的有效药物治疗新靶点，临床试验的总数并未减少。然而，审视2004年前后科学研究设计与首例患者入组试验之间的监管和行政障碍，并权衡这些障碍与缺乏证据表明该监管已实现提高患者安全性和试验质量这一目标的情况，彻底改革该CTD的必要性就变得显而易见。这样一项举措的主要目标应该是尽量减少官僚主义。对于德国的具体情况而言，将大学医院和医学院的责任和运营自由权交回给医师科学家，减少法律部门的干预，以及增加对学术研究者发起试验的公共财政支持都应该成为目标。
