RESUMO
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. METHODS: A survey was performed among the member and observer countries of the European Clinical Research Infrastructure Network (ECRIN), using a standardized questionnaire. Three rounds of data collection were performed to maximize completeness and comparability of the received answers. The survey aimed to describe the harmonization of academic clinical research processes at national level, to facilitate the exchange of expertise and experience among countries, and to identify new fields of action. RESULTS: Most scientific partners already have in place various working groups and harmonization activities at national level. Furthermore, they are involved in and open to sharing their know-how and documents. Since harmonization was mainly a bottom-up approach up until now, the extent and topics dealt with are diverse and there is only little cross-networking and cross-country exchange so far. CONCLUSIONS: Currently, the ECRIN member countries offer a very solid base and collaborative spirit for further aligning processes and exchanging best practices for clinical research in Europe. They can support a smooth implementation of the EU CTR and may act as single contact with consolidated expertise in a country.
RESUMO
BACKGROUND: Obesity-induced metabolic syndrome is a multiple risk factor for cardiovascular (CV) risk factors and type 2 diabetes, and ethnic minorities seem to have unfavourable medical risk factors in general more frequently than majority populations. OBJECTIVE: The aim of this study was to evaluate the prevalence of cardiovascular risk factors in relation to metabolic syndrome in the Roma population compared with the non-Roma population residing in the eastern part of Slovakia. RESULTS: 123 Roma and 79 non-Roma patients with metabolic syndrome were evaluated. Men between 40-55 years of age had 4.76-times higher odds and women 5.26-times higher odds for metabolic sydrome compared with the younger population. We found statistically significant higher waist circumference in the Roma subpopulation and higher body mass index as well, although in selected population with metabolic syndrome. HDL cholesterol was significantly lower in both Roma men and women, and LDL cholesterol was not significant in men and women with metabolic syndrome. Triglycerides levels were significantly higher in non-Roma women only. High-sensitivity C-reactive protein (hsCRP) values were not in correlation with age but were associated with the increasing number of fulfilled criteria for metabolic syndrome in both subgroups (Roma, non-Roma), independently of gender. CONCLUSION: Our study confirmed higher prevalence of obesity, metabolic syndrome and other CV risk factors associated with metabolic syndrome among younger Roma population, which may be associated with increased cardiovascular disease (CVD) morbidity and mortality among elderly Roma compared with non-Roma.
