The article is devoted to the pressing issue of using real world data (RWD) to prove effectiveness and safety of medical technologies. The authors consider the advantages and limitations of this approach compared to traditional randomized clinical trials. According to the main provisions of the article, RWD complement the results of clinical trials and make it possible to evaluate the effectiveness of drugs in everyday practice. Key stages of conducting RWD-based research are described such as research design, selection and evaluation of data source quality, analytical methods, ensuring transparency and reproducibility. Modern tools for planning and conducting RWD research are presented, for example, the HARPER protocol template, structured SPACE approach, and SPIFD data assessment tool. The features and limitations of RWD are discussed, including their unstructured nature, omissions, and inconsistency. The importance of observing the principles of transparency, integrity, and minimizing systematic errors when working with RWD is emphasized. There is a growing recognition of RWD by regulatory authorities and a need to develop standardized approaches to obtain it. In conclusion, the authors emphasize that with proper application of the research methodology, RWD can provide valuable information for decision-making in healthcare, complementing traditional clinical trials.
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This article highlights the ethical aspects that arise when the attending psychiatrist communicates with patients and their family members on the issues of planning a pregnancy. While counseling people with mental disorders about their reproductive plans, it is difficult from an ethical point of view to discuss some issues such as the risks of pathology in an unborn child and a possibility of reducing the risks, in particular the probability of genetic inheritance of a mental disorder; the expediency of discontinuing psychotropic drugs used by the expectant mother and/or father to treat or prevent a mental disorder exacerbations, given that drugs can affect the quality of reproductive biological material, whereas cancellation of therapy is associated with risks to the mental health of expectant parents; the need to inform the patient’s family members about his/her mental disorder, the treatment used and all available personal risks to offspring. Different literature sources, including domestic and foreign ones, were reviewed. The keywords used in literature were “genetics”, “psychiatry”, “ethical aspects of genetic counseling”, “psychopharmacotherapy during pregnancy”, “the effect of psychotropic drugs on spermatogenesis” with filtering by language (Russian and English) and document type. Two own clinical observations are presented. The purpose of the article is a comprehensive analysis of ethical aspects of counseling people with mental disorders on pregnancy planning by a psychiatrist.
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Discussion of the draft of the Recommendations on the Ethics of Neurotechnology proposed by UNESCO reveals the need to develop domestic regulations in this area, taking into account modern challenges of technological development. The purpose of the recommendations in the field of neuroethics is to ensure the human right to protect health, well-being and dignity associated with the risks of technological interference in the brain and mental processes, as well as threats associated with the social and humanitarian consequences of scientific and technological progress in the field of neuroscience and neurotechnology. The draft of domestic recommendations should establish obligations related to the ethical aspects of creation, implementation and use of neurotechnologies, which are currently not regulated by the legislation of the Russian Federation and acts of technical regulation. The objectives of the recommendations are to specify the terminological apparatus in accordance with the current regulatory legal acts, targeted separation of neurotechnologies for medical and non-medical purposes, ensuring safety for the health and well-being of vulnerable persons and social groups. In the socioeconomic aspect, development of domestic recommendations on the use of neurotechnologies shows the relevance of stimulating development of domestic production and socioeconomic growth in accordance with the national development goals of the Russian Federation until 2030.
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Treatment of rheumatoid arthritis is a complex and time-consuming process that does not always lead to significant results both due to poor effectiveness of drugs and drug toxicity. It means we need to search for new pharmacological targets to influence the pathological process, one of which is inhibition of proteinase-activated receptors 2 (PAR2 receptors) activity. In 2016–2019, synthesis of low-molecular-weight antagonists of PAR2 receptors belonging to 4,5-dihydroisoxazole-5-carboxamide derivatives was carried out, and in 2023 their anti-inflammatory efficacy was examined using the formaldehyde edema model. The most effective laboratory R004 compound was tested on a model of autoimmune pristane-induced inflammation in rats. During treatment of chronic inflammation in rats, R004 inhibited significant development of edema of feet, damage to small joints, and specific changes in the formula of white blood, and according to biochemical blood test led to normalization of liver and kidney functions and energy metabolism. R004 turned out to be more effective and safer than the comparator drugs such as diclofenac sodium and dexamethasone.
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