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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">transmed</journal-id><journal-title-group><journal-title xml:lang="ru">Трансляционная медицина</journal-title><trans-title-group xml:lang="en"><trans-title>Translational Medicine</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2311-4495</issn><issn pub-type="epub">2410-5155</issn><publisher><publisher-name>Almazov National Medical Research Centre, Saint Petersburg, Russia</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18705/2311-4495-2017-4-2-52-70</article-id><article-id custom-type="elpub" pub-id-type="custom">transmed-252</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ЭКСПЕРИМЕНТАЛЬНЫЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Experimental studies</subject></subj-group></article-categories><title-group><article-title>ЭКСПЕРИМЕНТАЛЬНЫЕ ИССЛЕДОВАНИЯ НА ЖИВОТНЫХ В ЭПОХУ ТРАНСЛЯЦИОННОЙ МЕДИЦИНЫ. КАКИМИ ИМ БЫТЬ?</article-title><trans-title-group xml:lang="en"><trans-title>ANIMAL EXPERIMENTS IN THE ERA OF TRANSLATIONAL MEDICINE. WHAT WOULD THEY BE?</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александров</surname><given-names>Илья Вадимович</given-names></name><name name-style="western" xml:lang="en"><surname>Aleksandrov</surname><given-names>Ilya V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>младший научный сотрудник НИО микроциркуляции и метаболизма миокарда Центра экспериментального биомоделирования Института экспериментальной медицины</p></bio><bio xml:lang="en"><p>Junior Researcher at the Department of Microcirculation and Myocardial Metabolism, Centre of Experimental Biomodeling, Institute of Experimental Medicine</p></bio><email xlink:type="simple">iliaalex@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Егорова</surname><given-names>Елена Игоревна</given-names></name><name name-style="western" xml:lang="en"><surname>Egorova</surname><given-names>Elena I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>младший научный сотрудник НИО микроциркуляции и метаболизма миокарда Центра экспериментального биомоделирования Института экспериментальной медицины</p></bio><bio xml:lang="en"><p>Junior Researcher at the Department of Microcirculation and Myocardial Metabolism, Centre of Experimental Biomodeling, Institute of Experimental Medicine</p></bio><email xlink:type="simple">egorova.elena@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Васина</surname><given-names>Елена Юрьевна</given-names></name><name name-style="western" xml:lang="en"><surname>Vasina</surname><given-names>Elena Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, доцент кафедры патофизиологии с курсом клинической патофизиологии</p><p>старший научный сотрудник НИО микроциркуляции и метаболизма миокарда Центра экспериментального биомоделирования Института экспериментальной медицины</p></bio><bio xml:lang="en"><p>PhD, Associate Professor of the Department of Pathophysiology and Clinical Pathophysiology</p><p>Senior Researcher at the Department of Microcirculation and Myocardial Metabolism, Centre of Experimental Biomodeling, Institute of Experimental Medicine,</p></bio><email xlink:type="simple">elenavasina17@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Новиков</surname><given-names>Владимир Константинович</given-names></name><name name-style="western" xml:lang="en"><surname>Novikov</surname><given-names>Vladimir K.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, профессор, главный научный сотрудник НИЛ биопротезирования и кардиопротекции Центра экспериментального биомоделирования Института экспериментальной медицины</p></bio><bio xml:lang="en"><p>MD, PhD, Professor, Chief Researcher at the Department of Bioprosthesis and Cardiac Protection, Centre of Experimental Biomodeling, Institute of Experimental Medicine</p></bio><email xlink:type="simple">vladnov43@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Матыко</surname><given-names>Павел Геннадьевич</given-names></name><name name-style="western" xml:lang="en"><surname>Matyko</surname><given-names>Pavel G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>младший научный сотрудник НИЛ биопротезирования и кардиопротекции Центра экспериментального биомоделирования Института экспериментальной медицины</p></bio><bio xml:lang="en"><p>Junior Researcher at the Department of Bioprosthesis and Cardiac Protection, Centre of Experimental Biomodeling, Institute of Experimental Medicine</p></bio><email xlink:type="simple">ya8904@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Галагудза</surname><given-names>Михаил Михайлович</given-names></name><name name-style="western" xml:lang="en"><surname>Galagudza</surname><given-names>Mikhail M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, член-корреспондент РАН, директор Института экспериментальной медицины</p><p>профессор кафедры патофизиологии с курсом клинической патофизиологии</p><p>ул. Пархоменко, д. 15 лит. Б, Санкт-Петербург, 194156</p></bio><bio xml:lang="en"><p>MD, PhD, Corresponding Member of the Russian Academy of Sciences, Director of the Institute of Experimental Medicine</p><p>Professor of the Department of Pathophysiology and Clinical Pathophysiology</p><p>Parkhomenko str. 15-B, Saint Petersburg, 194156</p></bio><email xlink:type="simple">galagudza@almazovcentre.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение &#13;
«Северо-Западный федеральный медицинский исследовательский &#13;
центр им. В. А. Алмазова» Минздрава России, Санкт-Петербург</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal Almazov North-West Medical Research Centre, Saint Petersburg</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение &#13;
«Северо-Западный федеральный медицинский исследовательский &#13;
центр им. В. А. Алмазова» Минздрава России, Санкт-Петербург; &#13;
Федеральное государственное бюджетное образовательное &#13;
учреждение высшего образования «Первый Санкт-Петербургский &#13;
государственный медицинский университет им. акад. И. П. Павлова» &#13;
Минздрава России, Санкт-Петербург</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal Almazov North-West Medical Research Centre, Saint Petersburg; &#13;
Academician I. P. Pavlov First Saint Petersburg State Medical University, Saint Petersburg</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2017</year></pub-date><pub-date pub-type="epub"><day>04</day><month>06</month><year>2017</year></pub-date><volume>4</volume><issue>2</issue><fpage>52</fpage><lpage>70</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Александров И.В., Егорова Е.И., Васина Е.Ю., Новиков В.К., Матыко П.Г., Галагудза М.М., 2017</copyright-statement><copyright-year>2017</copyright-year><copyright-holder xml:lang="ru">Александров И.В., Егорова Е.И., Васина Е.Ю., Новиков В.К., Матыко П.Г., Галагудза М.М.</copyright-holder><copyright-holder xml:lang="en">Aleksandrov I.V., Egorova E.I., Vasina E.Y., Novikov V.K., Matyko P.G., Galagudza M.M.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://transmed.almazovcentre.ru/jour/article/view/252">https://transmed.almazovcentre.ru/jour/article/view/252</self-uri><abstract><p>В настоящее время лабораторные животные используются в биомедицинских исследованиях для проверки гипотез о патогенезе заболеваний, поиска новых мишеней для фармакотерапии, доказательств механизма действия, доказательств эффективности и подтверждения безопасности новых лекарств. Однако результаты исследований при сложившейся практике их планирования и выполнения не всегда обеспечивают достаточный уровень доказательности для перехода к выполнению клинических исследований. Ключевыми понятиями, позволяющими обеспечить анализ сложившейся ситуации и наметить пути выхода из кризиса, являются понятия внутренней и внешней валидности, а также систематической ошибки. В настоящем обзоре кратко рассмотрены основные виды систематических ошибок, снижающих валидность экспериментальных исследований.</p><p>Инструментами, способствующими повышению трансляционного потенциала экспериментальных исследований, являются систематические обзоры и мета-анализы, международные рекомендации и проверочные списки, а также «обратная» трансляция неудачных клинических исследований.</p><p>Рекомендации и чеклисты, помогающие исследователям оценить соответствие планируемых и проводимых исследований «золотому стандарту», должны внедряться на различных уровнях, начиная с подготовки кадров, грантодающих организаций, комиссий по биоэтике и редакций научных журналов.</p><p>Предварительная регистрация экспериментальных работ и обеспечение доступа широкого круга исследователей к первичным данным после публикации результатов позволят сделать процесс проведения исследований более открытым и, следовательно, объективным.</p><p>Предложенные подходы могут способствовать преодолению кризиса транслируемости результатов экспериментальных исследований в практику и возвращению доверия широких кругов общественности к результатам экспериментальных биомедицинских исследований.</p></abstract><trans-abstract xml:lang="en"><p>Currently, laboratory animals are used in biomedical research to test hypotheses about the mechanisms of development and progression of the diseases, to search the new targets for pharmacotherapy, to test the safety and efficacy of new drugs. However, the results of experimental studies, with the established practice of their planning and performing, do not provide a sufficient level of evidence to go to performance of clinical trials. Key concepts, that allow the analysis of the current situation and outline the way out of the crisis, are the concepts of internal and external validity and bias. This review briefly describes the main types of systematic errors that reduce the validity of experimental research. Tools, that improve the translational potential of experimental studies, are systematic reviews and meta-analyzes, international guidelines and checklists, as well as the «reverse» translation of failed clinical trials. Guidelines and checklists that help researchers to assess the compliance of the planned and ongoing research to «gold standard», should be implemented at various levels, starting with the grantmaking organizations, bioethics committees and editorial boards of scientific journals. Pre-registration of experimental works and access of a wide range of researchers to the primary data after publication should make the research process more open and therefore objective. The above approaches might help to overcome the crisis of translatability of experimental results in practice and regain the trust of the general public to the results of biomedical experimental studies.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>экспериментальные исследования</kwd><kwd>лабораторные животные</kwd><kwd>трансляционная медицина</kwd><kwd>систематические ошибки</kwd><kwd>внутренняя и внешняя валидность</kwd><kwd>систематические обзоры</kwd><kwd>мета-анализы</kwd></kwd-group><kwd-group xml:lang="en"><kwd>experimental studies</kwd><kwd>laboratory animals</kwd><kwd>translational medicine</kwd><kwd>systematic errors</kwd><kwd>internal and external validity</kwd><kwd>systematic reviews</kwd><kwd>meta-analyzes</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Cook DJ, Tymianski M. 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