J 2019

European survey on national training activities in clinical research

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

Základní údaje

Originální název

European survey on national training activities in clinical research

Autoři

MAGNIN, A., V. C. IVERSEN, G. CALVO, B. CECETKOVA, O. DALE, Regina DEMLOVÁ (203 Česká republika, domácí), 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 a C. OHMANN

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30100 3.1 Basic medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

Impakt faktor

Impact factor: 1.832

Kód RIV

RIV/00216224:14110/19:00116835

Organizační jednotka

Lékařská fakulta

UT WoS

000502747300003

Klíčová slova anglicky

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

Příznaky

Mezinárodní význam, Recenzováno
Změněno: 12. 5. 2021 14:11, Mgr. Tereza Miškechová

Anotace

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.

Návaznosti

CZ.02.1.01/0.0/0.0/16_013/0001826, interní kód MU
(Kód CEP: EF16_013/0001826)
Název: CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií
Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN_PRO PACIENTY - zavádění inovativních moderních terapií, PO 1 Posilování kapacit pro kvalitní výzkum
LM2015090, projekt VaV
Název: Český národní uzel Evropské sítě infrastruktur klinického výzkumu (Akronym: CZECRIN)
Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, CZECRIN - Český národní uzel Evropské sítě infrastruktur klinického výzkumu