Department of Neurology with the Institute of Translational Neurology, University Hospital Münster, Münster, Germany.
Department of Geriatric Medicine, University Hospital Essen, Essen, Germany.
Eur J Neurol. 2021 May;28(5):1446-1452. doi: 10.1111/ene.14763. Epub 2021 Feb 26.
To provide an overview on the status of clinical research in neurology in Germany.
German university hospitals, nonuniversity hospitals, and neurological medical practices were surveyed regarding their clinical research activities during the period 2013 to 2017.
Fifty percent of university hospitals, 10.6% of nonuniversity hospitals, and 5.2% of medical practices in Germany responded to our questionnaire. More than 80% of the clinical studies conducted have been phase III/IV and noninterventional trials (NISs), whereas <1% have been phase I and 3.5% investigator-initiated trials (IITs). University hospitals have conducted most of the phase II-IV trials. NISs have been predominantly performed by medical practices. Fifty-six percent of the university hospitals and less of the nonuniversity institutions confirmed the implementation of standard operating procedures (SOPs). In university hospitals, on average, 11 physicians had acquired a good clinical practice certificate. Overall, 43% of all trials have been performed in neuroimmunology.
The status of clinical research in neurology in Germany is predominated by NISs and late-phase trials, potentially due to a general lack of easily accessible funding, which leads to a highly competitive environment and fewer opportunities to perform early-phase clinical trials as well as IITs. Our results indicate that there is substantial need for structured support for creating and implementing SOPs to maintain quality standards and guarantee uniformity of performance. This survey assessed many aspects of clinical research and serves as guidance for providing ideas for structured improvement of clinical research in neurology in Germany.
提供德国神经病学临床研究现状概述。
2013 年至 2017 年期间，对德国大学医院、非大学医院和神经科医疗实践就其临床研究活动进行了调查。
德国 50%的大学医院、10.6%的非大学医院和 5.2%的医疗实践对我们的问卷做出了回应。超过 80%的临床研究为 III/IV 期和非干预性试验（NIS），而<1%为 I 期，3.5%为研究者发起的试验（IIT）。大学医院开展了大部分 II-IV 期试验。NIS 主要由医疗实践开展。56%的大学医院和较少的非大学机构确认实施了标准操作程序（SOP）。在大学医院，平均有 11 名医生获得了良好临床实践证书。总体而言，43%的试验都在神经免疫学中进行。
德国神经病学临床研究的现状以 NIS 和后期试验为主，这可能是由于普遍缺乏容易获得的资金，导致竞争激烈，开展早期临床试验和 IIT 的机会较少。我们的结果表明，需要有系统的支持来制定和实施 SOP，以维持质量标准并保证性能的一致性。本调查评估了临床研究的许多方面，为提供结构化改善德国神经病学临床研究的思路提供了指导。
