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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
- Source :
- PLoS ONE, Vol 15, Iss 7, p e0236545 (2020), PLoS One (print), 1-17. Public Library of Science, ISSUE=July 31, 2020;STARTPAGE=1;ENDPAGE=17;ISSN=1932-6203;TITLE=PLoS One, PLoS ONE
- Publication Year :
- 2020
- Publisher :
- Public Library of Science (PLoS), 2020.
-
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.
- Subjects :
- Risk
Drug Research and Development
Epidemiology
Systems Engineering
media_common.quotation_subject
Science
Legislation
Social Sciences
Harmonization
Public administration
Research and Analysis Methods
Geographical locations
Order (exchange)
0502 economics and business
Medicine and Health Sciences
050602 political science & public administration
Clinical Trials
European Union
Regulations
Netherlands
media_common
Pharmacology
Clinical Trials as Topic
Multidisciplinary
05 social sciences
Legislature
Ambiguity
Hospitals
Social Control, Formal
0506 political science
Europe
Clinical trial
Work (electrical)
Medical Risk Factors
Engineering and Technology
Medicine
Law and Legal Sciences
Business
People and places
Clinical Medicine
Safety
Quality Assurance
Safety Studies
Inefficiency
050203 business & management
Research Article
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Volume :
- 15
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- PLoS ONE
- Accession number :
- edsair.doi.dedup.....d130b9c0d57c19baf2a45a36a80f7497