Sudhop Thomas, Grass Guido, Wessler Ignaz
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Geschäftsstelle der Ethikkommission, Medizinische Fakultät der Universität zu Köln, Kerpener Str. 62, 50937, Köln, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Aug;60(8):817-825. doi: 10.1007/s00103-017-2584-z.
The European Clinical Trials Regulation 536/2014 and the corresponding national legal transitions will require close cooperation between the federal higher authorities and ethics committees in the assessment of clinical trial applications involving medicinal products in humans. In preparation for this, a pilot project was launched to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, authorities and ethics committees the opportunity to familiarise themselves with the new procedures.
The aim of this paper is to examine all pilot project procedures of the first year since starting the pilot project at the end of 2015.
All 20 pilot projects completed in the first year were analysed for adherence to deadlines and results of the assessments.
Within the time limits specified in the EU regulation, 17 of 20 procedures were fully completed. In two cases, the sponsors slightly exceeded the additional delivery period. In one case, the sponsor withdrew the application within the pilot procedure. All 20 applications were processed jointly by the federal authorities and ethics committees, and in all cases a coordinated assessment report was successfully compiled on time. All 20 applications were approved, five of which were subject to suspensive conditions.
Compliance with the deadlines set by federal authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. The cooperation between the federal higher authorities and ethics committees was very successful from the perspective of the parties involved.
《欧洲临床试验法规（536/2014）》及相应的国家法律过渡要求联邦高级当局与伦理委员会在评估涉及人类药品的临床试验申请时密切合作。为此，启动了一个试点项目，以根据当前法律要求模拟该法规未来的流程，以便让申请人、当局和伦理委员会有机会熟悉新程序。
本文旨在研究自2015年底启动试点项目以来第一年的所有试点项目程序。
对第一年完成的所有20个试点项目进行分析，以检查其是否遵守期限以及评估结果。
在欧盟法规规定的期限内，20个程序中的17个已全部完成。有两个案例中，申办方略微超出了额外交付期。在一个案例中，申办方在试点程序中撤回了申请。所有20份申请均由联邦当局和伦理委员会联合处理，并且在所有案例中都按时成功编制了协调评估报告。所有20份申请均获批准，其中5份附有暂停条件。
遵守联邦当局和伦理委员会设定的期限表明，试点程序中建立的技术基础设施和流程功能齐全。从相关各方的角度来看，联邦高级当局与伦理委员会之间的合作非常成功。
