<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<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">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">clinvest-173</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>ОЦЕНКА МЕДИЦИНСКИХ ТЕХНОЛОГИЙ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>HEALTH TECHNOLOGY ASSESSMENT</subject></subj-group></article-categories><title-group><article-title>Исследования сравнительной эффективности</article-title><trans-title-group xml:lang="en"><trans-title></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>Колбин</surname><given-names>А. С.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Павлыш</surname><given-names>А. В.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Курылев</surname><given-names>А. А.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоусов</surname><given-names>Д. Ю.</given-names></name></name-alternatives><bio xml:lang="ru"><p>генеральный директор</p></bio><email xlink:type="simple">clinvest@mail.ru</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff xml:lang="ru" id="aff-1"><institution>Первый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университет</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-2"><institution>Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-3"><institution>Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. Павлова</institution><country>Russian Federation</country></aff><aff xml:lang="ru" id="aff-4"><institution>ООО "Центр фармакоэкономических исследований", г. Москва</institution><country>Russian Federation</country></aff><pub-date pub-type="collection"><year>2013</year></pub-date><pub-date pub-type="epub"><day>06</day><month>06</month><year>2018</year></pub-date><volume>0</volume><issue>1</issue><fpage>70</fpage><lpage>77</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Колбин А.С., Павлыш А.В., Курылев А.А., Белоусов Д.Ю., 2018</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="ru">Колбин А.С., Павлыш А.В., Курылев А.А., Белоусов Д.Ю.</copyright-holder><copyright-holder xml:lang="en">Колбин А.С., Павлыш А.В., Курылев А.А., Белоусов Д.Ю.</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.clinvest.ru/jour/article/view/173">https://www.clinvest.ru/jour/article/view/173</self-uri><abstract><p>Актуальность. Существует необходимость унифицировать термины «comparative effectiveness research» (CER), «relative effectiveness assessment» (REA) с целью их гармонизации, т.е. повышения доступности их применения. Цель статьи. Оценка основных понятий, относящихся к исследованию сравнительной эффективности, методологий их проведения. Методология. Проведён анализ публикаций в период с 1990 по 2012 гг. на предмет выявления данных, посвящённых исследованиям по сравнительной эффективности. Поиск производили в системах MEDLINE, Cochrane Library, EMBASE, eLibrary.ru. Выводы. Исследования сравнительной эффективности играют всё возрастающую роль в принятии решений о возмещении расходов на лекарственные средства. Это не только ведёт к распространению идеологии принятия решений, основанных на клинических доказательствах, но и формирует на фармацевтическом рынке значимую долю лекарственных средств с наилучшим соотношением «цена/качество». Представляется необходимым углубленное сотрудничество между странами в развитии методов для стандартизации данных исследований. Очевидно, существует необходимость создать в этой области согласованные международные руководства. Также важным шагом для обмена результатами оценки будет гармонизация и/или стандартизация подходов экстраполирования данных о действенности в данные об эффективности.</p></abstract><kwd-group xml:lang="ru"><kwd>comparative effectiveness assessment</kwd><kwd>health technology assessment</kwd><kwd>health related quality of life</kwd><kwd>исследования сравнительной эффективности</kwd><kwd>оценка медицинских технологий</kwd><kwd>оценка технологий здравоохранения</kwd><kwd>качество жизни</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">Авксентьева М.В., Омельяновский В.В. Международный опыт оценки технологий в здравоохранении / М. В. Авксентьева, В. В. Омельяновский // Медицинские технологии. Оценка и выбор — 2010.-№1.-С.52-58.</mixed-citation><mixed-citation xml:lang="en">Авксентьева М.В., Омельяновский В.В. Международный опыт оценки технологий в здравоохранении / М. В. Авксентьева, В. В. Омельяновский // Медицинские технологии. Оценка и выбор — 2010.-№1.-С.52-58.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">http://www.inahta.net</mixed-citation><mixed-citation xml:lang="en">http://www.inahta.net</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Berger M.L., Dreyer N., Anderson F., et al. Prospective Observational Studies to Assess Comparative Eﬀ ectiveness: Th e ISPOR Good Research Practices Task Force Report. Value Health. 2012;15(2):217-30.</mixed-citation><mixed-citation xml:lang="en">Berger M.L., Dreyer N., Anderson F., et al. Prospective Observational Studies to Assess Comparative Eﬀ ectiveness: Th e ISPOR Good Research Practices Task Force Report. Value Health. 2012;15(2):217-30.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Kleijnen S., George E., Goulden S., et al. Relative Eﬀ ectiveness Assessment of Pharmaceuticals: Similarities and Diﬀ erences in 29 Jurisdictions. Value In Health 2012;15:954 — 960.</mixed-citation><mixed-citation xml:lang="en">Kleijnen S., George E., Goulden S., et al. Relative Eﬀ ectiveness Assessment of Pharmaceuticals: Similarities and Diﬀ erences in 29 Jurisdictions. Value In Health 2012;15:954 — 960.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">High Level Pharmaceutical Forum. Core principles on relative eﬀ ectiveness. 2008.</mixed-citation><mixed-citation xml:lang="en">High Level Pharmaceutical Forum. Core principles on relative eﬀ ectiveness. 2008.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Public Law No: 111-5. H.R. 1. American Recovery and Reinvestment Act of 2009 signed by President Barack Obama on 2/17/2009.</mixed-citation><mixed-citation xml:lang="en">Public Law No: 111-5. H.R. 1. American Recovery and Reinvestment Act of 2009 signed by President Barack Obama on 2/17/2009.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">U.S. Department of Health and Human Services, Federal Coordinating Council for Comparative Eﬀ ectiveness Research. Report to the President and the Congress, 2009.</mixed-citation><mixed-citation xml:lang="en">U.S. Department of Health and Human Services, Federal Coordinating Council for Comparative Eﬀ ectiveness Research. Report to the President and the Congress, 2009.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Sorenson C. Use of comparative eﬀ ectiveness research in drug coverage and pricing decisions: a six-country comparison. Issue Brief (Commonw Fund) 2010;91:1—14.</mixed-citation><mixed-citation xml:lang="en">Sorenson C. Use of comparative eﬀ ectiveness research in drug coverage and pricing decisions: a six-country comparison. Issue Brief (Commonw Fund) 2010;91:1—14.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Zwarenstein M., Treweek S., Gagnier J.J., et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337:a2390.</mixed-citation><mixed-citation xml:lang="en">Zwarenstein M., Treweek S., Gagnier J.J., et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337:a2390.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Temple R.J. A regulatory authority’s opinion about surrogate endpoints. In: Nimmo WS, Tucker GT, eds., Clinical Measurement in Drug Evaluation. New York: Wiley, 1995.</mixed-citation><mixed-citation xml:lang="en">Temple R.J. A regulatory authority’s opinion about surrogate endpoints. In: Nimmo WS, Tucker GT, eds., Clinical Measurement in Drug Evaluation. New York: Wiley, 1995.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Kleist P. Composite endpoints for clinical trials: current perspectives. Int J Pharmaceut Med 2007;21:187—98.</mixed-citation><mixed-citation xml:lang="en">Kleist P. Composite endpoints for clinical trials: current perspectives. Int J Pharmaceut Med 2007;21:187—98.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Institute of Medicine of the National Academies. Medical Devices and the Public’s Health: Th e FDA 510(k) Clearance Process at 35 Years, Committee on the Public Health Eﬀ ectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Washington, D.C.: Institute of Medicine; 2011.</mixed-citation><mixed-citation xml:lang="en">Institute of Medicine of the National Academies. Medical Devices and the Public’s Health: Th e FDA 510(k) Clearance Process at 35 Years, Committee on the Public Health Eﬀ ectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Washington, D.C.: Institute of Medicine; 2011.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Chalkidou K., Tunis S., Lopert R., et al. Comparative eﬀ ectiveness research and evidence-based health policy: experience from four countries. Milbank Q</mixed-citation><mixed-citation xml:lang="en">Chalkidou K., Tunis S., Lopert R., et al. Comparative eﬀ ectiveness research and evidence-based health policy: experience from four countries. Milbank Q</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">; 87:339—67.</mixed-citation><mixed-citation xml:lang="en">; 87:339—67.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Levy A.R., Mitton C., Johnston K.M., et al. International comparison of comparative eﬀ ectiveness research in ﬁ ve jurisdictions: insights for the US. Pharmacoeconomics 2010; 28:813—30.</mixed-citation><mixed-citation xml:lang="en">Levy A.R., Mitton C., Johnston K.M., et al. International comparison of comparative eﬀ ectiveness research in ﬁ ve jurisdictions: insights for the US. Pharmacoeconomics 2010; 28:813—30.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Pharmaceutical Beneﬁ ts Advisory Committee. Guidelines for Preparing Submissions to the Pharmaceutical Beneﬁ ts Advisory Committee. Version 4.3. Canberra, Canada: Commonwealth of Australia, 2008.</mixed-citation><mixed-citation xml:lang="en">Pharmaceutical Beneﬁ ts Advisory Committee. Guidelines for Preparing Submissions to the Pharmaceutical Beneﬁ ts Advisory Committee. Version 4.3. Canberra, Canada: Commonwealth of Australia, 2008.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Clement F.M., Harris A., Li J.J., et al. Using eﬀ ectiveness and cost-eﬀ ectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 2009;302:1437—43.</mixed-citation><mixed-citation xml:lang="en">Clement F.M., Harris A., Li J.J., et al. Using eﬀ ectiveness and cost-eﬀ ectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. JAMA 2009;302:1437—43.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Cohen J., Faden L., Predaris S., et al. Patient access to pharmaceuticals: an international comparison. Eur J Health Econ 2007; 8:253—66.</mixed-citation><mixed-citation xml:lang="en">Cohen J., Faden L., Predaris S., et al. Patient access to pharmaceuticals: an international comparison. Eur J Health Econ 2007; 8:253—66.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Morgan S.G., McMahon M., Mitton C., et al. Centralized drug review processes in Australia, Canada, New Zealand, and the United Kingdom. Health Aﬀ (Millwood) 2006; 25:337—47.</mixed-citation><mixed-citation xml:lang="en">Morgan S.G., McMahon M., Mitton C., et al. Centralized drug review processes in Australia, Canada, New Zealand, and the United Kingdom. Health Aﬀ (Millwood) 2006; 25:337—47.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Zentner A., Velasco-Garrido M., Busse R. Methods for the comparative evaluation of pharmaceuticals. GMS Health Technol Assess 2005; 1:1—12.</mixed-citation><mixed-citation xml:lang="en">Zentner A., Velasco-Garrido M., Busse R. Methods for the comparative evaluation of pharmaceuticals. GMS Health Technol Assess 2005; 1:1—12.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Jönsson B. Relative eﬀ ectiveness and the European pharmaceutical market. Eur J Health Eco 2011; 12:97—102.</mixed-citation><mixed-citation xml:lang="en">Jönsson B. Relative eﬀ ectiveness and the European pharmaceutical market. Eur J Health Eco 2011; 12:97—102.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Goldberg N.H., Schneeweiss S., Kowal M.K., et al. Availability of comparative effi cacy data at the time of drug approval in the United States. JAMA 2011;305:1786—9.</mixed-citation><mixed-citation xml:lang="en">Goldberg N.H., Schneeweiss S., Kowal M.K., et al. Availability of comparative effi cacy data at the time of drug approval in the United States. JAMA 2011;305:1786—9.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">van Luijn J.C., Gribnau F.W., Leufk ens H.G. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol 2007; 63:159—62.</mixed-citation><mixed-citation xml:lang="en">van Luijn J.C., Gribnau F.W., Leufk ens H.G. Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol 2007; 63:159—62.</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Gartlehner G., Moore C.G. Direct versus indirect comparisons: a summary of the evidence. Int J Technol Assess Health Care 2008; 24:170—7.</mixed-citation><mixed-citation xml:lang="en">Gartlehner G., Moore C.G. Direct versus indirect comparisons: a summary of the evidence. Int J Technol Assess Health Care 2008; 24:170—7.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Bucher H.C., Guyatt G.H., Griffi th L.E., et al. Th e results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997; 50:683—91.</mixed-citation><mixed-citation xml:lang="en">Bucher H.C., Guyatt G.H., Griffi th L.E., et al. Th e results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997; 50:683—91.</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Song F., Altman D.G., Glenny A.M., et al. Validity of indirect comparison for estimating effi cacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003;326:472.</mixed-citation><mixed-citation xml:lang="en">Song F., Altman D.G., Glenny A.M., et al. Validity of indirect comparison for estimating effi cacy of competing interventions: empirical evidence from published meta-analyses. BMJ 2003;326:472.</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Song F., Loke Y.K., Walsh T., et al. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 2009;338:b1147.</mixed-citation><mixed-citation xml:lang="en">Song F., Loke Y.K., Walsh T., et al. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 2009;338:b1147.</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>
