Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands

Abstract

Background: National regulatory regimes for supervising ongoing clinical trials are affected by external challenges, both international, such as harmonization of EU legislation, and national, such as critical reviews of incidents. This study examines how supervisory bodies dealing with ongoing trials respond to external challenges of the past two decades and engage in institutional work to maintain, repair, or improve the Dutch regulatory regime. Methods: International and national regulatory documents were analyzed and interviews (n = 27) were conducted with various actors, including public supervisory bodies, hospital staff, and boards of directors. Findings: In the Netherlands, EU harmonization directed at centralizing and coordinating the regulatory regime for good clinical trial practice in Member States has paradoxically led to further fragmentation. The resulting ambiguity and inefficiency remained largely unresolved until a serious incident in a university hospital became a catalyst to clarify both the interconnected responsibilities and working relationships of various supervisory bodies. New legislation and regulatory methods were implemented, and actors outside the legislative framework became active in the field in order to strengthen supervision of ongoing trials, further multiplying yet also aligning with existing regulatory regimes. Conclusions: Public supervision of ongoing trials is fragmented in the Netherlands because the responsibilities and resources are unevenly distributed. In countries like the Netherlands, public supervisory bodies must do a great deal of institutional work to align with new EU regulations and still safeguard their traditional regulatory mechanisms that protect human safety. However, national regulatory traditions also offer new opportunities to strengthen the quality assurance of clinical trials.