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...
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| Format: | Article |
| Language: | English |
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BMC
2019-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3702-z |
| _version_ | 1811325448086355968 |
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| author | 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 |
| author_facet | 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 |
| author_sort | A. Magnin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T14:33:22Z |
| format | Article |
| id | doaj.art-f353c864d0794401a1b0ea6fceb45f0e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T14:33:22Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f353c864d0794401a1b0ea6fceb45f0e2022-12-22T02:43:07ZengBMCTrials1745-62152019-10-012011910.1186/s13063-019-3702-zEuropean survey on national training activities in clinical researchA. Magnin0V. Cabral Iversen1G. Calvo2B. Čečetková3O. Dale4R. Demlova5Gy. Blasko6F. Keane7G. L. Kovacs8C. Levy-Marchal9E. C. Monteiro10L. Palmisano11D. Pella12A. Portolés Pérez13O. Rascol14C. Schmid15F. Tay16H. von der Leyen17C. Ohmann18SCTO - Swiss Clinical Trial OrganisationNorCRIN – Norwegian Clinical Research Infrastructures NetworkSCReN – Spanish Clinical Research NetworkSLOVACRIN – Slovak Clinical Research Infrastructure NetworkNorCRIN – Norwegian Clinical Research Infrastructures NetworkCZECRIN – Czech Clinical Research Infrastructure NetworkHECRIN – Hungarian Clinical Research Infrastructure NetworkHRB CRCI – Health Research board, Clinical Research Coordination IrelandHECRIN – Hungarian Clinical Research Infrastructure NetworkF-CRIN – French Clinical Research Infrastructure NetworkPTCRIN - Portuguese Clinical Research Infrastructure NetworkItaCRIN - Italian Clinical Research Infrastructure NetworkSLOVACRIN – Slovak Clinical Research Infrastructure NetworkSCReN – Spanish Clinical Research NetworkF-CRIN – French Clinical Research Infrastructure NetworkSCTO - Swiss Clinical Trial OrganisationSCTO - Swiss Clinical Trial OrganisationKKSN – Netzwerk der Koordinierungszentren für Klinische StudienECRIN – European Clinical Research Infrastructure NetworkAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3702-zClinical researchClinical studyClinical trialSurveyTrainingGCP-training |
| spellingShingle | 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 European survey on national training activities in clinical research Trials Clinical research Clinical study Clinical trial Survey Training GCP-training |
| title | European survey on national training activities in clinical research |
| title_full | European survey on national training activities in clinical research |
| title_fullStr | European survey on national training activities in clinical research |
| title_full_unstemmed | European survey on national training activities in clinical research |
| title_short | European survey on national training activities in clinical research |
| title_sort | european survey on national training activities in clinical research |
| topic | Clinical research Clinical study Clinical trial Survey Training GCP-training |
| url | http://link.springer.com/article/10.1186/s13063-019-3702-z |
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