European survey on national harmonization in clinical research
Abstract Background Clinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR)....
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| Format: | Article |
| Language: | English |
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Wiley
2021-04-01
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| Series: | Learning Health Systems |
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| Online Access: | https://doi.org/10.1002/lrh2.10220 |
| _version_ | 1818641168197484544 |
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| author | Annette Magnin Valentina Cabral Iversen Gonzalo Calvo Beata Čečetková Ola Dale Regina Demlová György Blaskó Fionnuala Keane Gabor L. Kovacs Claire Levy‐Marchal Emilia C. Monteiro Lucia Palmisano Daniel Pella Antonio Portolés Olivier Rascol Caecilia Schmid Fabian Tay Heiko von derLeyen Christian Ohmann |
| author_facet | Annette Magnin Valentina Cabral Iversen Gonzalo Calvo Beata Čečetková Ola Dale Regina Demlová György Blaskó Fionnuala Keane Gabor L. Kovacs Claire Levy‐Marchal Emilia C. Monteiro Lucia Palmisano Daniel Pella Antonio Portolés Olivier Rascol Caecilia Schmid Fabian Tay Heiko von derLeyen Christian Ohmann |
| author_sort | Annette Magnin |
| collection | DOAJ |
| description | Abstract Background Clinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action. Results Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know‐how and documents. Since harmonization was mainly a bottom‐up approach up until now, the extent and topics dealt with are diverse and there is only little cross‐networking and cross‐country exchange so far. Conclusions Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country. |
| first_indexed | 2024-12-16T23:22:52Z |
| format | Article |
| id | doaj.art-fbee8b6652e9469a8a4e7df2c5adeb51 |
| institution | Directory Open Access Journal |
| issn | 2379-6146 |
| language | English |
| last_indexed | 2024-12-16T23:22:52Z |
| publishDate | 2021-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Learning Health Systems |
| spelling | doaj.art-fbee8b6652e9469a8a4e7df2c5adeb512022-12-21T22:12:07ZengWileyLearning Health Systems2379-61462021-04-0152n/an/a10.1002/lrh2.10220European survey on national harmonization in clinical researchAnnette Magnin0Valentina Cabral Iversen1Gonzalo Calvo2Beata Čečetková3Ola Dale4Regina Demlová5György Blaskó6Fionnuala Keane7Gabor L. Kovacs8Claire Levy‐Marchal9Emilia C. Monteiro10Lucia Palmisano11Daniel Pella12Antonio Portolés13Olivier Rascol14Caecilia Schmid15Fabian Tay16Heiko von derLeyen17Christian Ohmann18SCTO—Swiss Clinical Trial Organisation Bern SwitzerlandNorCRIN—Norwegian Clinical Research Infrastructure Network Trondheim NorwaySCReN—Spanish Clinical Research Network Madrid SpainSLOVACRIN—Slovak Clinical Research Infrastructure Network Košice SlovakiaNorCRIN—Norwegian Clinical Research Infrastructure Network Trondheim NorwayCZECRIN—Czech Clinical Research Infrastructure Network Brno Czech RepublicHECRIN—Hungarian Clinical Research Infrastructure Network Pécs HungaryHRB CRCI—Health Research board, Clinical Research Coordination Dublin IrelandHECRIN—Hungarian Clinical Research Infrastructure Network Pécs HungaryF‐CRIN—French Clinical Research Infrastructure Network Toulouse FrancePtCRIN—Portuguese Clinical Research Infrastructure Network Lisbon PortugalItaCRIN—Italian Clinical Research Infrastructure Network Rome ItalySLOVACRIN—Slovak Clinical Research Infrastructure Network Košice SlovakiaSCReN—Spanish Clinical Research Network Madrid SpainF‐CRIN—French Clinical Research Infrastructure Network Toulouse FranceSCTO—Swiss Clinical Trial Organisation Bern SwitzerlandSCTO—Swiss Clinical Trial Organisation Bern SwitzerlandKKSN—Netzwerk der Koordinierungszentren für Klinische Studien Berlin GermanyECRIN—European Clinical Research Infrastructure Network Paris FranceAbstract Background Clinical trials remain key to the development of evidence‐based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and “research infrastructures” for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe. Methods A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action. Results Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know‐how and documents. Since harmonization was mainly a bottom‐up approach up until now, the extent and topics dealt with are diverse and there is only little cross‐networking and cross‐country exchange so far. Conclusions Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.https://doi.org/10.1002/lrh2.10220clinical researchclinical studyclinical trialECRINEU 536/2014harmonization of processes |
| spellingShingle | Annette Magnin Valentina Cabral Iversen Gonzalo Calvo Beata Čečetková Ola Dale Regina Demlová György Blaskó Fionnuala Keane Gabor L. Kovacs Claire Levy‐Marchal Emilia C. Monteiro Lucia Palmisano Daniel Pella Antonio Portolés Olivier Rascol Caecilia Schmid Fabian Tay Heiko von derLeyen Christian Ohmann European survey on national harmonization in clinical research Learning Health Systems clinical research clinical study clinical trial ECRIN EU 536/2014 harmonization of processes |
| title | European survey on national harmonization in clinical research |
| title_full | European survey on national harmonization in clinical research |
| title_fullStr | European survey on national harmonization in clinical research |
| title_full_unstemmed | European survey on national harmonization in clinical research |
| title_short | European survey on national harmonization in clinical research |
| title_sort | european survey on national harmonization in clinical research |
| topic | clinical research clinical study clinical trial ECRIN EU 536/2014 harmonization of processes |
| url | https://doi.org/10.1002/lrh2.10220 |
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