Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes.

OBJECTIVES: Clinical trials provide one of the highest levels of evidence to support medical practice. Investigator initiated clinical trials (IICTs) answer relevant questions in clinical practice that may not be addressed by industry. For the first time, two European Countries are compared in terms of IICTs, respective funders and publications, envisaging to inspire others to use similar indicators to assess clinical research outcomes. METHODS: A retrospective systematic search of registered IICTs from 2004 to 2017, using four clinical trials registries was carried out in two European countries with similar population, GDP, HDI and medical schools but with different governmental models to fund clinical research. Each IICT was screened for sponsors, funders, type of intervention and associated publications, once completed. RESULTS: IICTs involving the Czech Republic and Portugal were n = 439 (42% with hospitals as sponsors) and n = 328 (47% with universities as sponsors), respectively. The Czech Republic and Portuguese funding agencies supported respectively 61 and 27 IICTs. Among these, trials with medicinal products represent 52% in Czech Republic and 4% in Portugal. In the first, a higher percentage of IICTs' publications in high impact factor journals with national investigators as authors was observed, when compared to Portugal (75% vs 15%). CONCLUSION: The better performance in clinical research by Czech Republic might be related to the existence of specific and periodic funding for clinical research, although further data are still needed to confirm this relationship. In upcoming years, the indicators used herein might be useful to tracking clinical research outcomes in these and other European countries.

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.

INTRODUCTION: Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. METHOD: A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. RESULTS: The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. CONCLUSION: The main shortcomings-specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

[Secondary dyslipidaemia after oral contraceptives]. / Sekundární dyslipidemie navozená soucasnými perorálními kontraceptivy.

THE AIM OF THE STUDY: To examine changes to blood lipid and lipoprotein levels following introduction of modern oral hormonal contraception agents and to evaluate atherogenic character of this dyslipidemia. METHODS, PATIENT SAMPLE: Forty four women of the mean age of 22.7 +/- 3.5 years, BMI 21.4 +/- 2.5 kg/sqm, waste line 71.9 +/- 7.1 cm and BP 115.7 +/- 12.2/70.1 +/- 8.3 mm Hg were included. Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, apolipoprotein A1 and apolipoprotein B levels were assessed before the introduction of contraception and 3 months into the treatment. RESULTS: Following 3 months of treatment, increase in the total cholesterol (4.19 +/- 0.80 vs 4.75 +/- 0.79 mmol/l; p < 0.001), LDL-cholesterol (2.10 +/- 0.64 vs 2.32 +/- 0.66 mmol/l; p = 0.23), HDL-cholesterol (1.71 +/- 0.42 vs 1.90 +/- 0.45 mmol/l; p < 0.001), triglycerides (0.85 +/- 0.36 vs 1.18 +/- 0.50 mmol/l; p < 0.001), apolipoprotein A1 (1.55 +/- 0.33 vs 1.88 +/- 0.44g/l; p < 0.001) and apolipoprotein B (0.58 +/- 0.15 vs 0.69 +/- 0.19 g/l; p < 0.001) levels was observed. The total cholesterol/HDL cholesterol and apolipoprotein B/apolipoprotein A1 ratios have not changed significantly between the two assessments. CONCLUSION: Three-month treatment with combined hormonal contraception resulted in statistically significantly increased concentrations of triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, apolipoprotein A1 and apolipoprotein B. At the same time, total cholesterol/HDL cholesterol and apolipoprotein B/apolipoprotein A1 ratios have not changed significantly and thus hormonal contraception-induced dyslipidemia should not be regarded as proatherogenic.

[Risk of smoking for the cardiovascular diseases starts even before the birth]. / Riziko kourení pro vznik kardiovaskulárních nemocí zacíná uz pred narozením.

Many proofs have confirmed that prenatal exposure to cigarette smoke is the important risk for the development of cardiovascular diseases (CVD) in later life. Such exposure influences on many CVD' determinants: obesity and adiposity, disturbances in glucose and blood lipids metabolism, hypertension, hypokinesis, blood vessel structure and heart reactivity. Expectant mothers have high moral motivation for the changes of their life style. They can substantially protect their babies' healthy development against risk factors if they will know and fully understand them. Our system of prenatal cure offers repeated and essential chance for active participations of physicians and midwifes in teaching both active and passive smoking pregnant women about risks of smoking and in motivation and consulting for smoking cessation.