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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">vedomostiregmed</journal-id><journal-title-group><journal-title xml:lang="ru">Регуляторные исследования и экспертиза лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Regulatory Research and Medicine Evaluation</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">3034-3062</issn><issn pub-type="epub">3034-3453</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/1991-2919-2021-11-2-167-173</article-id><article-id custom-type="elpub" pub-id-type="custom">vedomostiregmed-366</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>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Выбор конечных точек для клинических исследований офтальмологических препаратов</article-title><trans-title-group xml:lang="en"><trans-title>Selection of Endpoints for Clinical Studies of Ophthalmic Drugs</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0065-4990</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Комарова</surname><given-names>М. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Komarova</surname><given-names>M. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Комарова Марина Олеговна,</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Marina O. Komarova,</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">komarovaMO@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products,</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>17</day><month>08</month><year>2021</year></pub-date><volume>11</volume><issue>3</issue><fpage>167</fpage><lpage>173</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Комарова М.О., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Комарова М.О.</copyright-holder><copyright-holder xml:lang="en">Komarova M.O.</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://www.vedomostincesmp.ru/jour/article/view/366">https://www.vedomostincesmp.ru/jour/article/view/366</self-uri><abstract><p>Эффективные методы лечения некоторых социально значимых офтальмологических заболеваний до настоящего времени отсутствуют. Разработка терапевтических методов лечения таких заболеваний осложняется сложностью диагностирования и выбора конечных точек клинических исследований. Цель работы – анализ существующих подходов к выбору конечных точек клинических исследований препаратов, применяющихся для лечения офтальмологических заболеваний. При проведении клинических исследований эффективности новых лекарственных препаратов наряду с клиническими конечными точками используют суррогатные конечные точки. Используемые на настоящий момент суррогатные конечные точки не всегда релевантны и не отражают в полной мере динамику состояния пациента при заболеваниях глаз, отличающихся длительным и прогрессирующим течением. На основании данных научной литературы проведен анализ подходов к выбору конечных точек в исследованиях офтальмологических препаратов, предназначенных для лечения глаукомы, увеита, синдрома сухого глаза, возрастной макулярной дегенерации. Показано, что выбор суррогатных конечных точек для проведения клинического исследования должен учитывать особенности конкретного заболевания. Для оценки динамики изменения зрительных функций в большинстве случаев необходим комплексный подход, позволяющий получить наиболее полную характеристику состояния органа зрения при этом заболевании. В работе проанализирована возможность использования потенциальных суррогатных конечных точек для исследований наиболее распространенных глазных заболеваний и показано, что ни одна из них на настоящий момент не рекомендована для применения в ходе клинических исследований или в рутинной клинической практике.</p></abstract><trans-abstract xml:lang="en"><p>Until now, there have been no effective treatments for some ophthalmic diseases that have high social significance. Development of therapeutic approaches to such diseases may be complicated due to challenges in diagnosis and selection of clinical trial endpoints. The aim of the study was to analyse current approaches to selection of endpoints in clinical trials of ophthalmic drugs. Clinical efficacy studies of new medicinal products use surrogate endpoints in addition to clinical endpoints. However, currently used surrogate endpoints are not always relevant and do not fully reflect changes in the status of patients with chronic or progressive diseases. The study analysed published approaches to the selection of endpoints in clinical studies of ophthalmic drugs intended for the treatment of glaucoma, uveitis, dry eye syndrome, and age-related macular degeneration. It was demonstrated that the choice of surrogate endpoints in a clinical trial should take into account specific aspects of a particular disease. The assessment of dynamic patterns of changes in visual functions generally requires a complex approach for a comprehensive characterisation of the eye condition in a particular disease. The paper analyses the possibility of using potential surrogate endpoints in studies of the most common eye diseases, and highlights that none of them has been recommended for use in clinical trials or routine clinical practice.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>первичная конечная точка</kwd><kwd>суррогатная конечная точка</kwd><kwd>глаукома</kwd><kwd>внутриглазное давление</kwd><kwd>возрастная макулярная дегенерация</kwd><kwd>синдром сухого глаза</kwd><kwd>увеит</kwd></kwd-group><kwd-group xml:lang="en"><kwd>primary endpoint</kwd><kwd>surrogate endpoint</kwd><kwd>glaucoma</kwd><kwd>intraocular pressure</kwd><kwd>age-related macular degeneration</kwd><kwd>dry eye syndrome</kwd><kwd>uveitis</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00005-21-00 на проведение прикладных научных исследований (номер государственного учета НИР 121021800098-4).</funding-statement><funding-statement xml:lang="en">The study reported in this publication was carried out as part of a publicly funded research project No. 056-00005-21-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&amp;D public accounting No. 121021800098-4).</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Biomarkers Definitions Working Group. 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