BackgroundInvestigator-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.MethodsTo 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.ResultsThe 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.ConclusionsThere 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.
Background: Clinical trials remain key to the development of evidence-based medical practice. However, they are becoming increasingly complex, mainly in a multinational setting. To address these challenges, the European Union (EU) adopted the Clinical Trial Regulation EU No. 536/2014 (CTR). Once in force, the CTR will lead to more consistent rules and simplification of procedures for conducting clinical trials throughout the EU. Existing harmonization initiatives and "research infrastructures" for clinical trials may facilitate this process. This publication offers a snapshot of the current level of harmonization activities in academic clinical research in Europe.
The nosocomial infection was determinate as the direct cause of the dead in 49 (38.5%) patients. The highest mortality rate belonged to the PICU with 83.3% (10/12), follow by the NICU 71.4% (15/21); the mortality rate in the Newborn Unit was 70.5% (12/17); in contrast in the Surgery department the mortality rate was 0. In 65 of the cases at least one microorganism was isolated, being K. pneumonia Extended Spectrum Beta Lactamases (ESBLs), the most frequently isolated, 21.5% (14/65), it was also responsible of mostly of the mortal cases, and by area the most isolated from the NICU. No MRSA was isolated in this revision. Conclusion:Although the creation of the Nosocomial Infections Surveillances Committee, the nosocomial infections, its burden in costs, morbidity and mortality continuing being a big concern, especially in the NICU and Newborn Unit. Moreover, the high costs of the treatment for those kinds of infections sometimes are not affordable for patients in a weak healthcare system.
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