The Effects of EU Harmonization on National Public Supervision of Ongoing Trials

Background: International laws and regulations regulate and harmonize the conduct of clinical trials, but the existing tradition of national laws and regulation affects the way EU guidelines and regulations are implemented. Public supervision is often handled by competent authorities and national ethics committees. This study aims to examine how harmonization attempts of the EU affect public supervision of clinical trials in the Netherlands. We use institutional theories to analyze this. Methods: Regulation documents were analyzed, and interviews were conducted with inspectors from (inter)national supervisory bodies and with other actors. Results: The Netherlands already had existing systems and traditions. The efforts to implement EU guidelines and regulation have created a multilevel legislative framework. As a result, the organizational structure in public supervision is complex and fragmented. Decentralized medical research ethics committees (MRECs) and the Dutch Inspectorate are responsible for the supervision of ongoing trials. However, the MRECs linked to hospitals cannot fully process all safety reports for ongoing trials due to limited funding and capacity. The Dutch Inspectorate is responsible for conducting inspections; however, it does not assess research protocols and depends on information from sponsors, researchers, and other public supervisory bodies. Conclusions: EU policies intended to harmonize the regulation of clinical trials have generated positive effects for the approval phase of clinical trials. However, public supervision of ongoing trials is a weak spot when incongruity exists between EU guidelines and national structures. In countries like the Netherlands, actors need to do much institutional work to find alignment with EU regulations.