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.

Základní údaje

Originální název

European survey on national harmonization in clinical research

Autoři

MAGNIN, Anette (756 Švýcarsko), Valentina Cabral IVERSEN (578 Norsko), Gonzalo CALVO (724 Španělsko), Beata ČEČETKOVÁ (703 Slovensko), Ola DALE, Regina DEMLOVÁ (203 Česká republika, garant, domácí), György BLASKÓ (348 Maďarsko), Fionnuala KEANE (372 Irsko), Gabor L. KOVACS (348 Maďarsko), Claire LEVY-MARCHAL (250 Francie), Emilia C. MONTEIRO (620 Portugalsko), Lucia PALMISANO, Daniel PELLA (703 Slovensko), Antonio PORTOLÉS (724 Španělsko), Olivier RASCOL (250 Francie), Caecilia SCHMID, Fabian TAY, Heiko VON DER LEYEN a Christian OHMANN

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30230 Other clinical medicine subjects

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Kód RIV

RIV/00216224:14110/21:00121081

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000641767400005

Klíčová slova anglicky

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

Štítky

14110516, Excelence Science, INT, MU, RIV, rivok, user

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 8. 2. 2022 09:03, Mgr. Tereza Miškechová

Anotace

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.

Návaznosti

90128, velká výzkumná infrastruktura

Název: 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 a Christian OHMANN. European survey on national harmonization in clinical research. Learning Health Systems. Hoboken: Wiley, 2021, roč. 5, č. 2, s. 1-9. ISSN 2379-6146. Dostupné z: 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 a Christian OHMANN. European survey on national harmonization in clinical research. \textit{Learning Health Systems}. Hoboken: Wiley, 2021, roč.~5, č.~2, s.~1-9. ISSN~2379-6146. Dostupné z: https://dx.doi.org/10.1002/lrh2.10220.

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