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

• Published in: PloS one Vol. 15; no. 7; p. e0236545
• Main Authors: van Oijen, Jacqueline C. F., Wallenburg, Iris, Bal, Roland, Grit, Kor J.
• Format: Journal Article
• Language: English
• Published: San Francisco Public Library of Science 31.07.2020; Public Library of Science (PLoS)
• Subjects: Catalysts; Clinical trials; Confidentiality; Engineering and Technology; Health risks; Human medical experimentation; Human subjects; Legislation; Management; Medical research; Medicine and Health Sciences; Methods; People and places; Quality assurance; Quality control; R&D; Regulation; Regulatory mechanisms (biology); Repair; Research & development; Research and Analysis Methods; Safety and security measures; Social Sciences; Theory; Traditions; Netherlands; United Kingdom > UK

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...