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.

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.