European survey on national training activities in clinical
research

J 2019

European survey on national training activities in clinical research

MAGNIN, A., V. C. IVERSEN, G. CALVO, B. CECETKOVA, O. DALE et. al.

Basic information

Original name

European survey on national training activities in clinical research

Authors

MAGNIN, A., V. C. IVERSEN, G. CALVO, B. CECETKOVA, O. DALE, Regina DEMLOVÁ (203 Czech Republic, belonging to the institution), G. BLASKO, F. KEANE, G. L. KOVACS, C. LEVY-MARCHAL, E. C. MONTEIRO, L. PALMISANO, D. PELLA, A. P. PEREZ, O. RASCOL, C. SCHMID, F. TAY, H. VON DER LEYEN and C. OHMANN

Edition

CONTEMPORARY CLINICAL TRIALS, New York, Elsevier Science, 2019, 1551-7144

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30100 3.1 Basic medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.832

RIV identification code

RIV/00216224:14110/19:00116835

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1186/s13063-019-3702-z

UT WoS

000502747300003

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: Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods: To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results: The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions: There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.

Links

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(CEP code: EF16_013/0001826)

Name: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií

Investor: Ministry of Education, Youth and Sports of the CR, Priority axis 1: Strengthening capacities for high-quality research

LM2015090, research and development project

Name: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Acronym: CZECRIN)

Investor: Ministry of Education, Youth and Sports of the CR

Citovat

MAGNIN, A., V. C. IVERSEN, G. CALVO, B. CECETKOVA, O. DALE, Regina DEMLOVÁ, G. BLASKO, F. KEANE, G. L. KOVACS, C. LEVY-MARCHAL, E. C. MONTEIRO, L. PALMISANO, D. PELLA, A. P. PEREZ, O. RASCOL, C. SCHMID, F. TAY, H. VON DER LEYEN and C. OHMANN. European survey on national training activities in clinical research. CONTEMPORARY CLINICAL TRIALS. New York: Elsevier Science, 2019, vol. 20, No 1, p. 1-9. ISSN 1551-7144. Available from: https://dx.doi.org/10.1186/s13063-019-3702-z.

@article{1689278,
   author = {Magnin, A. and Iversen, V. C. and Calvo, G. and Cecetkova, B. and Dale, O. and Demlová, Regina and Blasko, G. and Keane, F. and Kovacs, G. L. and LevyandMarchal, C. and Monteiro, E. C. and Palmisano, L. and Pella, D. and Perez, A. P. and Rascol, O. and Schmid, C. and Tay, F. and von der Leyen, H. and Ohmann, C.},
   article_location = {New York},
   article_number = {1},
   doi = {http://dx.doi.org/10.1186/s13063-019-3702-z},
   keywords = {Clinical research; Clinical study; Clinical trial; Survey; Training; GCP-training; ECRIN; Career options; Training requirements; Clinical study personnel},
   language = {eng},
   issn = {1551-7144},
   journal = {CONTEMPORARY CLINICAL TRIALS},
   title = {European survey on national training activities in clinical research},
   url = {https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-019-3702-z},
   volume = {20},
   year = {2019}
}

TY  - JOUR
ID  - 1689278
AU  - Magnin, A. - Iversen, V. C. - Calvo, G. - Cecetkova, B. - Dale, O. - Demlová, Regina - Blasko, G. - Keane, F. - Kovacs, G. L. - Levy-Marchal, C. - Monteiro, E. C. - Palmisano, L. - Pella, D. - Perez, A. P. - Rascol, O. - Schmid, C. - Tay, F. - von der Leyen, H. - Ohmann, C.
PY  - 2019
TI  - European survey on national training activities in clinical research
JF  - CONTEMPORARY CLINICAL TRIALS
VL  - 20
IS  - 1
SP  - 1-9
EP  - 1-9
PB  - Elsevier Science
SN  - 15517144
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://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-019-3702-z
N2  - Background: Investigator-initiated clinical studies (IITs) are crucial to generate reliable evidence that answers questions of day-to-day clinical practice. Many challenges make IITs a complex endeavour, for example, IITs often need to be multinational in order to recruit a sufficient number of patients. Recent studies highlighted that well-trained study personnel are a major factor to conduct such complex IITs successfully. As of today, however, no overview of the European training activities, requirements and career options for clinical study personnel exists. Methods: To fill this knowledge gap, a survey was performed in all 11 member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardised questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the landscape of academic training opportunities, to facilitate the exchange of expertise and experience among countries and to identify new fields of action. Results: The survey found that training for Good Clinical Practice (GCP) and investigator training is offered in all but one country. A specific training for study nurses or study coordinators is also either provided or planned in ten out of eleven countries. A majority of countries train in monitoring and clinical pharmacovigilance and offer specific training for principal investigators but only few countries also train operators of clinical research organisations (CRO) or provide training for methodology and quality management systems (QMS). Minimal requirements for study-specific functions cover GCP in ten countries. Only three countries issued no requirements or recommendations regarding the continuous training of study personnel. Yet, only four countries developed a national strategy for training in clinical research and the career options for clinical researchers are still limited in the majority of countries. Conclusions: There is a substantial and impressive investment in training and education of clinical research in the individual ECRIN countries. But so far, a systematic approach for (top-down) strategic and overarching considerations and cross-network exchange is missing. Exchange of available curricula and sets of core competencies between countries could be a starting point for improving the situation.
ER  -

MAGNIN, A., V. C. IVERSEN, G. CALVO, B. CECETKOVA, O. DALE, Regina DEMLOVÁ, G. BLASKO, F. KEANE, G. L. KOVACS, C. LEVY-MARCHAL, E. C. MONTEIRO, L. PALMISANO, D. PELLA, A. P. PEREZ, O. RASCOL, C. SCHMID, F. TAY, H. VON DER LEYEN and C. OHMANN. European survey on national training activities in clinical research. \textit{CONTEMPORARY CLINICAL TRIALS}. New York: Elsevier Science, 2019, vol.~20, No~1, p.~1-9. ISSN~1551-7144. Available from: https://dx.doi.org/10.1186/s13063-019-3702-z.

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