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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">myrwd</journal-id><journal-title-group><journal-title xml:lang="ru">Реальная клиническая практика: данные и доказательства</journal-title><trans-title-group xml:lang="en"><trans-title>Real-World Data &amp; Evidence</trans-title></trans-title-group></journal-title-group><issn pub-type="epub">2782-3784</issn><publisher><publisher-name>Publishing House OKI</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.37489/2782-3784-myrwd-8</article-id><article-id custom-type="edn" pub-id-type="custom">UJOEUB</article-id><article-id custom-type="elpub" pub-id-type="custom">myrwd-11</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>РЕГУЛЯТОРНАЯ СИСТЕМА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REGULATORY SYSTEM</subject></subj-group></article-categories><title-group><article-title>Китайский опыт по использованию доказательств, полученных на основе данных реальной клинической практики в процессе разработки, исследования и оценки лекарственных препаратов</article-title><trans-title-group xml:lang="en"><trans-title>Chinese experience on using RWE to support drug research, development and evaluation</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1919-2909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колбин</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolbin</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колбин Алексей Сергеевич, д. м. н., профессор, заведующий кафедрой клинической фармакологии и доказательной медицины; профессор кафедры фармакологии медицинского факультета Санкт-Петербургского государственного университета </p><p>Санкт-Петербург</p></bio><email xlink:type="simple">alex.kolbin@mail.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2164-8290</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Д. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Belousov</surname><given-names>D. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Белоусов Дмитрий Юрьевич, Генеральный директор </p><p>Москва</p></bio><bio xml:lang="en"><p>Moscow</p></bio><email xlink:type="simple">clinvest@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им академика И.П. Павлова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FSBEI HE I.P. Pavlov SPbSMU MOH Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ООО «Центр фармакоэкономических исследований»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>LLC “Center for Pharmacoeconomics Research”</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2022</year></pub-date><pub-date pub-type="epub"><day>15</day><month>03</month><year>2022</year></pub-date><volume>2</volume><issue>1</issue><fpage>17</fpage><lpage>27</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Колбин А.С., Белоусов Д.Ю., 2022</copyright-statement><copyright-year>2022</copyright-year><copyright-holder xml:lang="ru">Колбин А.С., Белоусов Д.Ю.</copyright-holder><copyright-holder xml:lang="en">Kolbin A.S., Belousov D.Y.</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.myrwd.ru/jour/article/view/11">https://www.myrwd.ru/jour/article/view/11</self-uri><abstract><p>В статье описываются регуляторные подходы к сбору, анализу и использованию данных реальной клинической практики, которые применяются в Китае.</p></abstract><trans-abstract xml:lang="en"><p>The article describes the regulatory approaches to the collection, analysis and usage of real-world data applied in China.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>данные реальной клинической практики</kwd><kwd>регуляторные подходы</kwd><kwd>китайский опыт</kwd></kwd-group><kwd-group xml:lang="en"><kwd>real-world data</kwd><kwd>regulatory approaches</kwd><kwd>Chinese experience</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">Sun YX, Wei FF, Yang Y. Opportunities and Challenges in Using Real-World Evidence to Support Regulatory Decision Making for Drug and Medical Devices. Chinese Journal of Pharmacovigilance. 2017;(06):353–8.</mixed-citation><mixed-citation xml:lang="en">Sun YX, Wei FF, Yang Y. Opportunities and Challenges in Using Real-World Evidence to Support Regulatory Decision Making for Drug and Medical Devices. Chinese Journal of Pharmacovigilance. 2017;(06):353–8.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Wu YL, Chen XY, Yang ZM, et al (Wu Jieping Medical Foundation, Chinese Thoracic Oncology Group). Guidance on Real World Research. 2018.</mixed-citation><mixed-citation xml:lang="en">Wu YL, Chen XY, Yang ZM, et al (Wu Jieping Medical Foundation, Chinese Thoracic Oncology Group). Guidance on Real World Research. 2018.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">General Office of the CPC Central Committee, General Office of the State Council. Opinions on Deepening the Evaluation, Review and Approval System Reform and Encouraging Innovation of Drugs and Medical Devices. 2017.</mixed-citation><mixed-citation xml:lang="en">General Office of the CPC Central Committee, General Office of the State Council. Opinions on Deepening the Evaluation, Review and Approval System Reform and Encouraging Innovation of Drugs and Medical Devices. 2017.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">ADAPTABLE Investigators. Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study protocol. http://pcornet.org/wp-content/uploads/2015/06/ADAPTABLE-Protocol-Final-Draft-6-4-15_for-post_06-26-.pdf. Published June, 2015, 5.</mixed-citation><mixed-citation xml:lang="en">ADAPTABLE Investigators. Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study protocol. http://pcornet.org/wp-content/uploads/2015/06/ADAPTABLE-Protocol-Final-Draft-6-4-15_for-post_06-26-.pdf. Published June, 2015, 5.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Berger M, Daniel G, Frank K, et al. A frame work for regulatory use of real-world evidence. White paper prepared by the Duke Margolis Center for Health Policy. 2017, 6.</mixed-citation><mixed-citation xml:lang="en">Berger M, Daniel G, Frank K, et al. A frame work for regulatory use of real-world evidence. White paper prepared by the Duke Margolis Center for Health Policy. 2017, 6.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Cave A, Kurz X, Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for Europe. Clinical pharmacology and therapeutics. 2019;106(1):36.</mixed-citation><mixed-citation xml:lang="en">Cave A, Kurz X, Arlett P. Real-world data for regulatory decision making: challenges and possible solutions for Europe. Clinical pharmacology and therapeutics. 2019;106(1):36.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Dreyer NA. Advancing a framework for regulatory use of real-world evidence: when real is reliable. Therapeutic innovation &amp; regulatory science. 2018;52(3):362–8.</mixed-citation><mixed-citation xml:lang="en">Dreyer NA. Advancing a framework for regulatory use of real-world evidence: when real is reliable. Therapeutic innovation &amp; regulatory science. 2018;52(3):362–8.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Egger M, Moons KGM, Fletcher C, et al. GetReal: from efficacy in clinical trials to relative effectiveness in the real world. Research synthesis methods. 2016;7(3):278–81.</mixed-citation><mixed-citation xml:lang="en">Egger M, Moons KGM, Fletcher C, et al. GetReal: from efficacy in clinical trials to relative effectiveness in the real world. Research synthesis methods. 2016;7(3):278–81.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375(5):454–63.</mixed-citation><mixed-citation xml:lang="en">Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375(5):454–63.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Institute of Medicine 2009. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press. https://doi.org/10.17226/12648.</mixed-citation><mixed-citation xml:lang="en">Institute of Medicine 2009. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press. https://doi.org/10.17226/12648.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">James S. Importance of post-approval real-word evidence. European Heart Journal-Cardiovascular Pharmacotherapy. 2018;4(1):10–11.</mixed-citation><mixed-citation xml:lang="en">James S. Importance of post-approval real-word evidence. European Heart Journal-Cardiovascular Pharmacotherapy. 2018;4(1):10–11.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Kohl S. Joint HMA/EMA task force on big data established. Eur J Hosp Pharm. 2017;24(3): 180–90.</mixed-citation><mixed-citation xml:lang="en">Kohl S. Joint HMA/EMA task force on big data established. Eur J Hosp Pharm. 2017;24(3): 180–90.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Lash TL, Fox MP, Fink AK. Applying quantitative bias analysis to epidemiologic data[M]. Springer Science &amp; Business Media, 2011.</mixed-citation><mixed-citation xml:lang="en">Lash TL, Fox MP, Fink AK. Applying quantitative bias analysis to epidemiologic data[M]. Springer Science &amp; Business Media, 2011.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Makady A, de Boer A, Hillege H, et al. What is real-world data? A review of definitions based on literature and stakeholder interviews. Value in health. 2017;20(7):858–65.</mixed-citation><mixed-citation xml:lang="en">Makady A, de Boer A, Hillege H, et al. What is real-world data? A review of definitions based on literature and stakeholder interviews. Value in health. 2017;20(7):858–65.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Olariu E, Papageorgakopoulou C, Bovens SM, et al. Real world evidence in Europe: a snapshot of its current status. Value in Health. 2016;19(7):A498.</mixed-citation><mixed-citation xml:lang="en">Olariu E, Papageorgakopoulou C, Bovens SM, et al. Real world evidence in Europe: a snapshot of its current status. Value in Health. 2016;19(7):A498.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Roland M, Torgerson DJ. Understanding controlled trials: What are pragmatic trials? BMJ. 1998;316(7127):285.</mixed-citation><mixed-citation xml:lang="en">Roland M, Torgerson DJ. Understanding controlled trials: What are pragmatic trials? BMJ. 1998;316(7127):285.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence — what is it and what can it tell us. N Engl J Med. 2016;375(23):2293–7.</mixed-citation><mixed-citation xml:lang="en">Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence — what is it and what can it tell us. N Engl J Med. 2016;375(23):2293–7.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA. 2014;311(23):2381–2.</mixed-citation><mixed-citation xml:lang="en">Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA. 2014;311(23):2381–2.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">US Food and Drug Administration. Framework for FDA’s real-world evidence program. December 2018. 2019.</mixed-citation><mixed-citation xml:lang="en">US Food and Drug Administration. Framework for FDA’s real-world evidence program. December 2018. 2019.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, eds. Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide. AHRQ Publication No. 12(13) — EHC099. Rockville, MD: Agency for Healthcare Research and Quality, January 2013. www.effectivehealthcare.ahrq.gov/Methods-OCER.cfm.</mixed-citation><mixed-citation xml:lang="en">Velentgas P, Dreyer NA, Nourjah P, Smith SR, Torchia MM, eds. Developing a Protocol for Observational Comparative Effectiveness Research: A User’s Guide. AHRQ Publication No. 12(13) — EHC099. Rockville, MD: Agency for Healthcare Research and Quality, January 2013. www.effectivehealthcare.ahrq.gov/Methods-OCER.cfm.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Annals of internal medicine. 2007;147(8):573–7.</mixed-citation><mixed-citation xml:lang="en">Von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Annals of internal medicine. 2007;147(8):573–7.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
