European survey on national training activities in clinical research

A Magnin, V Cabral Iversen, G Calvo, B Čečetková, O Dale, R Demlova, Gy Blasko, F Keane, G L Kovacs, C Levy-Marchal, E C Monteiro, L Palmisano, D Pella, A Portolés Pérez, O Rascol, C Schmid, F Tay, H von der Leyen, C Ohmann

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Abstract

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.

Original languageEnglish
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 29 Oct 2019

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Teaching
Research Personnel
Research
Pharmacovigilance
Developed Countries
Curriculum
Nurses
Surveys and Questionnaires
Organizations
Education
Clinical Studies

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Magnin, A., Iversen, V. C., Calvo, G., Čečetková, B., Dale, O., Demlova, R., ... Ohmann, C. (2019). European survey on national training activities in clinical research. Trials, 20(1). https://doi.org/10.1186/s13063-019-3702-z
Magnin, A ; Iversen, V Cabral ; Calvo, G ; Čečetková, B ; Dale, O ; Demlova, R ; Blasko, Gy ; Keane, F ; Kovacs, G L ; Levy-Marchal, C ; Monteiro, E C ; Palmisano, L ; Pella, D ; Portolés Pérez, A ; Rascol, O ; Schmid, C ; Tay, F ; von der Leyen, H ; Ohmann, C. / European survey on national training activities in clinical research. In: Trials. 2019 ; Vol. 20, No. 1.
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title = "European survey on national training activities in clinical research",
abstract = "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.",
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Magnin, A, Iversen, VC, Calvo, G, Čečetková, B, Dale, O, Demlova, R, Blasko, G, Keane, F, Kovacs, GL, Levy-Marchal, C, Monteiro, EC, Palmisano, L, Pella, D, Portolés Pérez, A, Rascol, O, Schmid, C, Tay, F, von der Leyen, H & Ohmann, C 2019, 'European survey on national training activities in clinical research', Trials, vol. 20, no. 1. https://doi.org/10.1186/s13063-019-3702-z

European survey on national training activities in clinical research. / Magnin, A; Iversen, V Cabral; Calvo, G; Čečetková, B; Dale, O; Demlova, R; Blasko, Gy; Keane, F; Kovacs, G L; Levy-Marchal, C; Monteiro, E C; Palmisano, L; Pella, D; Portolés Pérez, A; Rascol, O; Schmid, C; Tay, F; von der Leyen, H; Ohmann, C.

In: Trials, Vol. 20, No. 1, 29.10.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - European survey on national training activities in clinical research

AU - Magnin, A

AU - Iversen, V Cabral

AU - Calvo, G

AU - Čečetková, B

AU - Dale, O

AU - Demlova, R

AU - Blasko, Gy

AU - Keane, F

AU - Kovacs, G L

AU - Levy-Marchal, C

AU - Monteiro, E C

AU - Palmisano, L

AU - Pella, D

AU - Portolés Pérez, A

AU - Rascol, O

AU - Schmid, C

AU - Tay, F

AU - von der Leyen, H

AU - Ohmann, C

PY - 2019/10/29

Y1 - 2019/10/29

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.

AB - 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.

U2 - 10.1186/s13063-019-3702-z

DO - 10.1186/s13063-019-3702-z

M3 - Article

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -

Magnin A, Iversen VC, Calvo G, Čečetková B, Dale O, Demlova R et al. European survey on national training activities in clinical research. Trials. 2019 Oct 29;20(1). https://doi.org/10.1186/s13063-019-3702-z