Status of clinical research in neurology in Germany-A national survey

被引:2
|
作者
Lohmann, Lisa [1 ]
Lammerskitten, Anna [1 ]
Korsen, Melanie [1 ]
Dodel, Richard [2 ]
Gaul, Charly [3 ]
Hamer, Hajo M. [4 ]
Kleineberg, Nina N. [5 ,6 ,7 ]
Ludolph, Albert C. [8 ,9 ]
Mayer, Geert [10 ]
Poli, Sven [11 ,12 ]
Saur, Dorothee [13 ]
Steinhoff, Bernhard J. [14 ,15 ]
Timmermann, Lars [16 ]
Klotz, Luisa [1 ]
Meuth, Sven G. [1 ]
机构
[1] Univ Hosp Munster, Dept Neurol, Inst Translat Neurol, Munster, Germany
[2] Univ Hosp Essen, Dept Geriatr Med, Essen, Germany
[3] Migraine & Headache Clin Koenigstein, Koenigstein, Germany
[4] Univ Erlangen Nurnberg, Epilepsy Ctr, Dept Neurol, Erlangen, Germany
[5] Univ Cologne, Fac Med, Dept Neurol, Cologne, Germany
[6] Univ Cologne, Univ Hosp Cologne, Cologne, Germany
[7] Inst Neurosci & Med INM 3, Res Ctr Julich, Cognit Neurosci, Julich, Germany
[8] Univ Hosp Ulm, Dept Neurol, Ulm, Germany
[9] German Ctr Neurodegenerat Dis DZNE, Ulm, Germany
[10] Hephata Clin, Sleep Disorder Unit, Schwalmstadt, Germany
[11] Eberhard Karls Univ Tubingen, Dept Neurol & Stroke, Tubingen, Germany
[12] Eberhard Karls Univ Tubingen, Hertie Inst Clin Brain Res, Tubingen, Germany
[13] Univ Leipzig, Dept Neurol, Med Ctr, Leipzig, Germany
[14] Epilepsy Ctr Kork, Kehl, Germany
[15] Univ Hosp Freiburg, Dept Neurol, Freiburg, Germany
[16] Univ Hosp Marburg, Marburg, Germany
关键词
clinical research; Germany; good clinical practice; survey;
D O I
10.1111/ene.14763
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background and purpose To provide an overview on the status of clinical research in neurology in Germany. Methods German university hospitals, nonuniversity hospitals, and neurological medical practices were surveyed regarding their clinical research activities during the period 2013 to 2017. Results 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. Conclusions 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.
引用
收藏
页码:1446 / 1452
页数:7
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