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European survey on national training activities in clinical research.
Trials. 2019 Oct 29; 20(1):616.T

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.

Authors+Show Affiliations

SCTO - Swiss Clinical Trial Organisation, Bern, Switzerland.NorCRIN - Norwegian Clinical Research Infrastructures Network, Trondheim, Norway.SCReN - Spanish Clinical Research Network, Madrid, Spain.SLOVACRIN - Slovak Clinical Research Infrastructure Network, Bratislava, Slovakia.NorCRIN - Norwegian Clinical Research Infrastructures Network, Trondheim, Norway.CZECRIN - Czech Clinical Research Infrastructure Network, Prague, Czech Republic.HECRIN - Hungarian Clinical Research Infrastructure Network, Budapest, Hungary.HRB CRCI - Health Research board, Clinical Research Coordination Ireland, Dublin, Ireland.HECRIN - Hungarian Clinical Research Infrastructure Network, Budapest, Hungary.F-CRIN - French Clinical Research Infrastructure Network, Paris, France.PTCRIN - Portuguese Clinical Research Infrastructure Network, Lisboa, Portugal.ItaCRIN - Italian Clinical Research Infrastructure Network, Rome, Italy.SLOVACRIN - Slovak Clinical Research Infrastructure Network, Bratislava, Slovakia.SCReN - Spanish Clinical Research Network, Madrid, Spain.F-CRIN - French Clinical Research Infrastructure Network, Paris, France.SCTO - Swiss Clinical Trial Organisation, Bern, Switzerland.SCTO - Swiss Clinical Trial Organisation, Bern, Switzerland.KKSN - Netzwerk der Koordinierungszentren für Klinische Studien, Hannover, Germany.ECRIN - European Clinical Research Infrastructure Network, Kaiserswerther Str, 70 40477, Düsseldorf, Germany. Christian.Ohmann@med.uni-duesseldorf.de.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31665085

Citation

Magnin, A, et al. "European Survey On National Training Activities in Clinical Research." Trials, vol. 20, no. 1, 2019, p. 616.
Magnin A, Iversen VC, Calvo G, et al. European survey on national training activities in clinical research. Trials. 2019;20(1):616.
Magnin, A., Iversen, V. C., Calvo, G., Čečetková, B., Dale, O., Demlova, R., Blasko, G., 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. (2019). European survey on national training activities in clinical research. Trials, 20(1), 616. https://doi.org/10.1186/s13063-019-3702-z
Magnin A, et al. European Survey On National Training Activities in Clinical Research. Trials. 2019 Oct 29;20(1):616. PubMed PMID: 31665085.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2019/10/29/ PY - 2019/05/03/received PY - 2019/09/04/accepted PY - 2019/10/31/entrez PY - 2019/10/31/pubmed PY - 2020/4/28/medline KW - Career options KW - Clinical research KW - Clinical study KW - Clinical study personnel KW - Clinical trial KW - ECRIN KW - GCP-training KW - Survey KW - Training KW - Training requirements SP - 616 EP - 616 JF - Trials JO - Trials VL - 20 IS - 1 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/31665085/European_survey_on_national_training_activities_in_clinical_research_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3702-z DB - PRIME DP - Unbound Medicine ER -