The description of the international practice of governmental funding of biomedical research is a significant aspect of development of the methodology for prioritization of funding of science (both basic and applied research) in the Russian Federation. The information about mechanisms of allocation of the governmental budget in biomedical research and about focus themes within biomedical research founded in open information sources is very limited.
The article presents an analysis of the general legal regulation of medical research in Russian Federation. Issues to be improved are mentioned. The main legal act for management of scientific activities is the Federal Law of 23 August 1996 N 127-FZ "On Science and State Technical Policy". The basic legal norms of the law are outdated and need to be adjusted, and primar items to update are main concepts. Basic definitions of the law need to be clarified and brought into line with international law. In the allocation of budgetary resources and the planning of this activity it is essential to shift the attention from the control over the funds expenditure to the estimation of research results. This will facilitate more effective and transparent spending of budget funds for scientific research in Russian Federation.
Objectives. There is no consistent evidence of clinical efficacy of Pentaglobin for reducing mortality in newborns and older children with bacterial infections and sepsis. The aim of the study was to update evidence by considering recent clinical trials and analyzing age populations and comparators separately. Methods. We searched publications in PubMed and the Cochrane Library in December 2014 and in October 2015. All-cause mortality was analyzed, and systematic review using meta-analysis and indirect comparison was carried out. Results. Three meta-analyses and 7RCTs were considered, including 6 trials studied the effect of Pentaglobin in newborns, and one in children 1-24 months old. All interventions were applied with basic therapy (BT). In newborns mortality is lower in Pentaglobin than in all comparators groups, RR 0.51 [0.32; 0.82], and in BT with or without placebo, RR 0.56 [0.34; 0.91]. Children under 24 months receiving Pentaglobin also had lower mortality than in all comparators group, RR 0.51 [0.36; 0.72]. Indirect comparison of IgM and IgG in adults showed no differences, in newborns the difference is in favor of IgM, RR 0.51 [0.32; 0.82]. Conclusion. Pentaglobin is effective in reducing all-cause mortality in newborns with bacterial infection or sepsis in comparison with any comparators (BT with or without placebo, albumin, IgG), in children under 24 months in comparison to BT with or without albumin. Further head-to-head clinical trials are needed to enhance evidence.
iimatinib is currently the most widely used tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia (CML) in Russia. When patients develop resistance or intolerance to imatinib, second generation tyrosine kinase inhibitors (Tkis) are used. in Russia, nilotinib, dasatinib and bosutinib are registered in second-line, however only dasatinib is included in the government drug reimbursement program. The aim of this study was to conduct a pharmacoeconomic comparison of nilotinib, dasatinib and bosutinib as second-line treatments for patients with CML from the Russian healthcare system perspective. Materials and methods. Using the clinical trial data we developed a Markov model of CML progression on nilotinib, dasatinib or bosutinib second-line therapy and calculated the medical costs per patient. Both cost- effectiveness analysis and budget-impact analysis reflected the local practice and the drug reimbursement approval process. Results. The average medical cost (per year) for nilotinib (1 683 thousand rubles or US$27 075) was 8.4% lower than that for dasatinib and 35.2% lower than for bosutinib. The 4-year total medical cost of treatment with nilotinib was 4 372 thousand rubles (US$ 70 336), which was 13.9% lower compared to dasatinib and 37.3% lower compared to bosutinib. nilotinib also had a lower cost/effectiveness ratio (US$ 1 602, 1 910 and 2 537 per life month for nilotinib, dasatinib and bosutinib, respectively). The estimated number of patients in Russia who need second-line treatment for CML is 996 patients. if nilotinib were included in the Government Reimbursement Program, a saving of 771 million rubles (US$ 12,4 million) over four years would be reached. Conclusions. When compared with dasatinib or bosutinib, nilotinib is the cost-saving option for the second-line treatment of CML patients in Russia.
In article, it is noticed that the situation which has developed in Russia brightly illustrates interdependence of system manufacture - a society - environment. Infringement of one of components conducts to infringement of functioning of all system. At the moment there are some positions of principle concerning decision-making on maintenance of quality of environment.