European survey on national harmonization in clinical research

J 2021

European survey on national harmonization in clinical research

MAGNIN, Anette, Valentina Cabral IVERSEN, Gonzalo CALVO, Beata ČEČETKOVÁ, Ola DALE et. al.

Basic information

Original name

European survey on national harmonization in clinical research

Authors

MAGNIN, Anette (756 Switzerland), Valentina Cabral IVERSEN (578 Norway), Gonzalo CALVO (724 Spain), Beata ČEČETKOVÁ (703 Slovakia), Ola DALE, Regina DEMLOVÁ (203 Czech Republic, guarantor, belonging to the institution), György BLASKÓ (348 Hungary), Fionnuala KEANE (372 Ireland), Gabor L. KOVACS (348 Hungary), Claire LEVY-MARCHAL (250 France), Emilia C. MONTEIRO (620 Portugal), Lucia PALMISANO, Daniel PELLA (703 Slovakia), Antonio PORTOLÉS (724 Spain), Olivier RASCOL (250 France), Caecilia SCHMID, Fabian TAY, Heiko VON DER LEYEN and Christian OHMANN

Edition

Learning Health Systems, Hoboken, Wiley, 2021, 2379-6146

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

RIV identification code

RIV/00216224:14110/21:00121081

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1002/lrh2.10220

UT WoS

000641767400005

Keywords in English

Clinical research; Clinical study; Clinical trial; Survey; Training; GCP-training; ECRIN; Career options; Training requirements; Clinical study personnel

Abstract

V originále

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.

Links

90128, large research infrastructures

Name: CZECRIN III

Citovat

MAGNIN, Anette, 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 DER LEYEN and Christian OHMANN. European survey on national harmonization in clinical research. Learning Health Systems. Hoboken: Wiley, 2021, vol. 5, No 2, p. 1-9. ISSN 2379-6146. Available from: https://dx.doi.org/10.1002/lrh2.10220.

@article{1736824,
   author = {Magnin, Anette and Iversen, Valentina Cabral and Calvo, Gonzalo and Čečetková, Beata and Dale, Ola and Demlová, Regina and Blaskó, György and Keane, Fionnuala and Kovacs, Gabor L. and LevyandMarchal, Claire and Monteiro, Emilia C. and Palmisano, Lucia and Pella, Daniel and Portolés, Antonio and Rascol, Olivier and Schmid, Caecilia and Tay, Fabian and von der Leyen, Heiko and Ohmann, Christian},
   article_location = {Hoboken},
   article_number = {2},
   doi = {http://dx.doi.org/10.1002/lrh2.10220},
   keywords = {Clinical research; Clinical study; Clinical trial; Survey; Training; GCP-training; ECRIN; Career options; Training requirements; Clinical study personnel},
   language = {eng},
   issn = {2379-6146},
   journal = {Learning Health Systems},
   title = {European survey on national harmonization in clinical research},
   url = {https://onlinelibrary.wiley.com/doi/full/10.1002/lrh2.10220},
   volume = {5},
   year = {2021}
}

TY  - JOUR
ID  - 1736824
AU  - Magnin, Anette - Iversen, Valentina Cabral - Calvo, Gonzalo - Čečetková, Beata - Dale, Ola - Demlová, Regina - Blaskó, György - Keane, Fionnuala - Kovacs, Gabor L. - Levy-Marchal, Claire - Monteiro, Emilia C. - Palmisano, Lucia - Pella, Daniel - Portolés, Antonio - Rascol, Olivier - Schmid, Caecilia - Tay, Fabian - von der Leyen, Heiko - Ohmann, Christian
PY  - 2021
TI  - European survey on national harmonization in clinical research
JF  - Learning Health Systems
VL  - 5
IS  - 2
SP  - 1-9
EP  - 1-9
PB  - Wiley
SN  - 23796146
KW  - Clinical research
KW  - Clinical study
KW  - Clinical trial
KW  - Survey
KW  - Training
KW  - GCP-training
KW  - ECRIN
KW  - Career options
KW  - Training requirements
KW  - Clinical study personnel
UR  - https://onlinelibrary.wiley.com/doi/full/10.1002/lrh2.10220
L2  - https://onlinelibrary.wiley.com/doi/full/10.1002/lrh2.10220
N2  - 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.
ER  -

MAGNIN, Anette, 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 DER LEYEN and Christian OHMANN. European survey on national harmonization in clinical research. \textit{Learning Health Systems}. Hoboken: Wiley, 2021, vol.~5, No~2, p.~1-9. ISSN~2379-6146. Available from: https://dx.doi.org/10.1002/lrh2.10220.

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