Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities
Background: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standa...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422000746 |
| _version_ | 1818518975038881792 |
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| author | Sofia Di Martino Rieke van der Graaf |
| author_facet | Sofia Di Martino Rieke van der Graaf |
| author_sort | Sofia Di Martino |
| collection | DOAJ |
| description | Background: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States. From January 31st, 2022, it will be possible to submit clinical studies through a new portal, namely the Clinical Trials Information System. Since not complying to the Regulation implies not participating in clinical trials, many European countries underwent changes in national documents and related procedures. In The Netherlands, the Site Suitability Declaration, a document necessary to ascertain the adequacy of a site to perform a trial, was reviewed. Methods: In our research, we investigated the status of the VGO implementation during a transition period among different stakeholders involved in the start-up process through a validated questionnaire and subsequent semi-structured interviews. Results: This project showed a slow-paced implementation, linked to communication and organizational challenges but also to a negative approach towards the change. Nevertheless, some stakeholders expressed constructive feedback as well, indicating the VGO as an upgrade. The latter was mainly achieved through establishing a trustful relationship with other stakeholders, undergoing additional adjustments, and having a positive mindset. Conclusions: This research pointed at a still too scarce collaboration between stakeholders, who should rather actively contribute to achieve the implementation goal. |
| first_indexed | 2024-12-11T01:17:33Z |
| format | Article |
| id | doaj.art-487d8c488131416d947c0ccfeaea4e69 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-11T01:17:33Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-487d8c488131416d947c0ccfeaea4e692022-12-22T01:25:49ZengElsevierContemporary Clinical Trials Communications2451-86542022-08-0128100957Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunitiesSofia Di Martino0Rieke van der Graaf1Utrecht University, Utrecht, the Netherlands; Corresponding author.Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the NetherlandsBackground: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States. From January 31st, 2022, it will be possible to submit clinical studies through a new portal, namely the Clinical Trials Information System. Since not complying to the Regulation implies not participating in clinical trials, many European countries underwent changes in national documents and related procedures. In The Netherlands, the Site Suitability Declaration, a document necessary to ascertain the adequacy of a site to perform a trial, was reviewed. Methods: In our research, we investigated the status of the VGO implementation during a transition period among different stakeholders involved in the start-up process through a validated questionnaire and subsequent semi-structured interviews. Results: This project showed a slow-paced implementation, linked to communication and organizational challenges but also to a negative approach towards the change. Nevertheless, some stakeholders expressed constructive feedback as well, indicating the VGO as an upgrade. The latter was mainly achieved through establishing a trustful relationship with other stakeholders, undergoing additional adjustments, and having a positive mindset. Conclusions: This research pointed at a still too scarce collaboration between stakeholders, who should rather actively contribute to achieve the implementation goal.http://www.sciencedirect.com/science/article/pii/S2451865422000746European clinical trials regulationThe NetherlandsVGO implementationLocal feasibility |
| spellingShingle | Sofia Di Martino Rieke van der Graaf Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities Contemporary Clinical Trials Communications European clinical trials regulation The Netherlands VGO implementation Local feasibility |
| title | Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities |
| title_full | Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities |
| title_fullStr | Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities |
| title_full_unstemmed | Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities |
| title_short | Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities |
| title_sort | embracing the european regulation in the netherlands vgo implementation status its threats and opportunities |
| topic | European clinical trials regulation The Netherlands VGO implementation Local feasibility |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422000746 |
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