Pregnant women are a very special category of patients. The risk-benefit ratio of using various drugs in this case presents a significant medical, social and ethical problem. The increase in the age of onset of the first pregnancy is associated with the increasing prevalence of chronic pathology. Obesity, cardiovascular diseases, diabetes mellitus, hypo- or hyperfunction of the thyroid gland, as well as many other conditions contribute to the active use of drugs of various pharmacological groups throughout the entire period of pregnancy, including early periods. The current practice of pharmacotherapy in pregnant women is based mainly on the use of drugs with an uncertain teratogenic risk. Not including pregnant women in clinical trials is an ethical issue as significant as their potential inclusion. Previously, for a long time, vulnerable categories included generally all women of reproductive age, whose inclusion in clinical trials became possible only in the mid-1990s. Pregnant women were considered vulnerable until 2019. The orphan status of pregnant women in terms of inclusion in clinical trials limits their right to receive highly effective and safe medical care, which makes it relevant to review the existing ethical principles in relation to this category of patients and a to perform a detailed analysis of existing barriers for certain types of drug trials.
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The published review is devoted to ten-volume edition entitled Bioethics Library published by Veche publishing house. The series was edited by Academician Chuchalin AG. It consisted of various works related to bioethical issues. The edition is mainly intended for students and teachers of bioethics of Russian medical universities. The series has a wide historical framework. It examines the works by Avicenna and Immanuel Kant, translated books by Sweden researchers Johansson I and Lynøe N. Texts by Russian physicians and thinkers (Berdyayev NA, Veresayev VV, Uglov FG, Botkin ES, Voyno-Yasenetsky VF (St. Luka Krymsky), Pirogov NI, Pavlov IP, Koni AF, Ilyin IA, Metropolitan Antony Surozhsky, etc.) are published as well. A collection of official documents on bioethical regulation is presented as a separate volume. The edition comprises self-evaluation questions. The texts included into the Bioethics Library make the readers familiar with the history of bioethics building and formation as an anthropologic project. Bioethics is based on the value of life and human integrity, it protects the human being and society, and, as a result, possesses regulatory functions. In the edition, special attention is paid to Russian authors and their view of bioethical issues. It is assumed that examination, popularization and content analysis of the series are particularly relevant within the context of national bioethics development.
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