• Thomas Sudhop, Guido Grass, and Ignaz Wessler.
• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
• Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Aug 1; 60 (8): 817-825.

BackgroundThe 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.ObjectivesThe 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.Materials And MethodsAll 20 pilot projects completed in the first year were analysed for adherence to deadlines and results of the assessments.ResultsWithin 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.ConclusionsCompliance 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.

14 keywords...

hide…