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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

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 trial...

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Autores principales: van Oijen, Jacqueline C. F., Wallenburg, Iris, Bal, Roland, Grit, Kor J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394415/
https://www.ncbi.nlm.nih.gov/pubmed/32735568
http://dx.doi.org/10.1371/journal.pone.0236545
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author van Oijen, Jacqueline C. F.
Wallenburg, Iris
Bal, Roland
Grit, Kor J.
author_facet van Oijen, Jacqueline C. F.
Wallenburg, Iris
Bal, Roland
Grit, Kor J.
author_sort van Oijen, Jacqueline C. F.
collection PubMed
description 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.
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spelling pubmed-73944152020-08-07 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 van Oijen, Jacqueline C. F. Wallenburg, Iris Bal, Roland Grit, Kor J. PLoS One Research Article 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. Public Library of Science 2020-07-31 /pmc/articles/PMC7394415/ /pubmed/32735568 http://dx.doi.org/10.1371/journal.pone.0236545 Text en © 2020 van Oijen et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
van Oijen, Jacqueline C. F.
Wallenburg, Iris
Bal, Roland
Grit, Kor J.
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394415/
https://www.ncbi.nlm.nih.gov/pubmed/32735568
http://dx.doi.org/10.1371/journal.pone.0236545
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