European survey on national training activities in clinical research.

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.

[Prevalence study of nosocomial infections in university hospitals in the Czech Republic]. / Prevalencní studie nozokomiálních nákaz ve fakultních nemocnicích v Ceské republice.

OBJECTIVE: In 2005-2010, a nosocomial infection prevalence study was conducted in 12 university hospitals, namely at the departments of surgery, urology, neurology, cardiology, neurosurgery, otorhinolaryngology, and traumatology. The primary objective was to evaluate the overall epidemiological situation of nosocomial infections (NI) at the highest risk departments of selected healthcare facilities in the Czech Republic and to characterize the NI detected. METHODS: To collect data, a questionnaire survey method was used, as it suited the routine operation conditions in healthcare facilities and was inexpensive, easy to understand, reproducible, and repeatable if needed. The questionnaire was designed according to the protocol recommended by the working group HELICS (Hospital in Europe Link for Infection Control through Surveillance). In each of the participating hospitals, the medical records of all patients hospitalized at the respective departments were analyzed. The patient data, hospitalization data, potential risk factors, and occurrence of hospital infection, if any, were derived from the medical records and entered in the questionnaire. RESULTS: Overall, data on 1889 hospitalized patients were analyzed. Eighty-one confirmed NI cases were found, i.e. the prevalence rate in this study was 4.3% (the percentage of HI per the number of hospitalized patients), which is in agreement with the recent data reported in the European Union. The most common causative agents were Pseudomonas spp. (16%), Staphylococcus aureus (15%), Escherichia coli (12%), Proteus spp. (10%), and Klebsiella spp. (4%), with the urinary tract (41%) and respiratory tract (23%) being affected most often.

[Current situation in clinical trials with vaccines in the Czech Republic]. / Soucasnost klinických studií ockovacích látek v Ceské republice.

Clinical trials are an important part of clinical research. The conduction of clinical trials is strictly regulated and has to comply with an approved protocol. Local regulatory authorities, independent ethic committees, sponsors of clinical trials as well as the investigators are involved from the submission until the very end of the trial. All clinical trials performed in the Czech Republic have to be approved by the State Institute for Drug Control and by the Ethics Committee. The regulatory bodies and independent ethics committees evaluate and continuously supervise the justification and protocol of the clinical trial, quality of the investigational medicinal products and, primarily, the safety of the participants (patients and/or healthy volunteers) in clinical trials. In the Czech Republic there are many advanced clinical research centres, either located in private practices or within hospitals. The investigators are able to conduct a wide variety of clinical trials and recruit a high number of subjects for the trials, as well as to comply with the Good Clinical Practice guidelines and other regulatory requirements. The aim of this article is to summarise the current situation of clinical trials in the Czech Republic as well as the opportunities for getting involved in clinical trials and obligations arising for health professionals from such an involvement.

[Immunogenicity of vaccines against viral hepatitis A and B in the population above 40 years of age -- impact of risk factors]. / Imunogenita vakcín proti virovým hepatitidám A a B u osob starsích 40 let -- vliv rizikových faktoru.

UNLABELLED: The immune reaction following vaccination against viral hepatitis A (HAV) and viral hepatitis B (HBV) can be influenced by a variety of factors. Among the most important are age, gender and body weight. STUDY OBJECTIVE: This prospective randomized study compared immunogenicity of available vaccines against HAV and HBV infections in the population above 40 years of age and the impact of risk factors. MATERIAL AND METHODS: The vaccinated subjects were divided into 3 groups based on the vaccine used. Within each group, the subjects were equally distributed by age, gender and body weight. The vaccine was always applied intramuscularly in the deltoid. Group 1 was given the combined vaccine Twinrix (GSK) against HAV and HBV infections in the left deltoid; group 2 was vaccinated with the Havrix vaccine against HAV (GSK) in the right deltoid and with the Engerix-B vaccine against HBV (GSK) in the left deltoid; group 3 received the Vaqta vaccine against HAV (Sanofi Pasteur) in the right deltoid and the HB VAX PRO against HBV (Sanofi-Pasteur) in the left deltoid. RESULTS: The following anti-HBs seroprotectivity rates: 92%, 80% and 71%, and anti-HAV seropositivity rates: 97%, 99% and 99%, were observed at 1 month after the end of the complete vaccination in groups 1, 2 and 3, respectively. The anti-HBs seroprotectivity rate was statistically significantly higher in group 1. The anti-HAV seropositivity rates were comparable (did not significantly differ) in all three study groups. CONCLUSION: The impact of age was revealed: the immune response decreases with increasing age. The lowest immunogenicity of the vaccines against HAV and HBV infections was observed in subjects above 60 years of age. Males achieved lower geometric mean titres (GMT) of antibodies and lower seroprotectivity rates compared to females. The impact of body weight was also observed, with the obese subjects showing the lowest immune response. The anti-HBs reactivity was significantly influenced by the vaccine used. The combined vaccine against HAV and HBV infections (Twinrix) induced higher anti-HBs seroprotectivity and comparable anti-HAV seropositivity when compared with the other monovalent study vaccines in the population above 40 years of age.

[Seroprevalence of antibodies against hepatitis A virus and hepatitis B virus in nonvaccinated adult population over 40 years of age]. / Séroprevalence protilátek proti viru hepatitidy A, viru hepatitidy B u nevakcinované dospelé populace starsí 40 let.

STUDY OBJECTIVE: To determine prevalence rates of antibodies against hepatitis A virus (HAV) and hepatitis B virus (HBV) in the general adult male and female population over 40 years of age with no history of viral hepatitis A (VHA) and viral hepatitis B (VHB) who have never been vaccinated against hepatitis and to assess the cost-effectiveness of the pre-vaccination serological screening. MATERIAL AND METHODS: In 2003-2004, a total of 972 persons of three age categories: 41-50 years, 51-60 years, 61 and more years, were screened. Persons with a history of VHA and/or VHB and those who had been vaccinated against hepatitis were not included in the study. The following four indicators were determined from a 5 ml specimen of whole venous blood by electrochemiluminiscence assay: total anti-HAV antibodies, total anti-HBc antibodies, anti-HBs antibodies and HBsAg, as the most suitable markers of experienced hepatitis or previous vaccination. RESULTS: The prevalence rates of anti-HAV antibodies were lower in females compared to males for all of the three age categories. These antibodies were detected in 16.8%, 52.9% and 77.5% of 41-50-year-olds, 51-60-year-olds and > or = 61-year-olds, respectively. The total prevalence rate for the three age groups was 61.6%. The anti-HBc antibody seroprevalence rates were 1.9%, 5.3% and 6.1%, respectively. CONCLUSION: The results show high prevalence of VHA in higher age groups. Such a high seroprevalence of antibodies in nonvaccinated persons with no history of viral hepatitis is suggestive of a very frequent incidence of asymptomatic infection. For this reason, the prevaccination screening of anti-HAV antibodies is cost-effective in the population over 50 years of age but is not justified in persons under 40 years of age. Prevaccination screening for anti-HBc antibodies appears not to be cost-effective regardless of age in view of their low prevalence in the Czech population.