vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-26Research ArticleОБЗОРНЫЕ И ПРОБЛЕМНЫЕ СТАТЬИGENERAL AND TOPICAL ARTICLESТрансляционные исследования. Перспективы в РоссииTranslational research. Prospects in RussiaКолбинА. С.KolbinA. S.alex.kolbin@mail.ruГапешинР. А.GapeshinR. A.noemail@neicon.ruМалышевС. М.MalyshevS. M.noemail@neicon.ruПервый Санкт-Петербургский государственный медицинский университет им. акад. И.П. ПавловаРоссияFirst Pavlov State Medical University of Saint PetersburgRussian FederationСанкт-Петербургский государственный университетРоссияSaint Petersburg State UniversityRussian Federation201513022018014044Copyright © Колбин А.С., Гапешин Р.А., Малышев С.М., 20182018Колбин А.С., Гапешин Р.А., Малышев С.М.Kolbin A.S., Gapeshin R.A., Malyshev S.M.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/26

В последние годы в здравоохранении пришли к пониманию, что любая медицинская технология должна быть подвергнута экспертной оценке. Одним из ведущих вопросов в оценке медицинских технологий является возможность переноса данных действенности на эффективность. Действенность и эффективность являются также составными частями трансляционных (операционных) исследований, осуществляющих переход от фундаментальных знаний к клинической практике. Изучение действенности и эффективности, а также проведение трансляционного исследования в целом, позволяет оценить целесообразность применения медицинской технологии в определенной группе населения по клиническим исходам и затратам. Проблема разрозненности биомедицинских данных может быть решена путем проведения трансляционных (операционных) исследований, в рамках которых медицинская технология оценивается и с позиций фундаментальной науки. Процесс трансляции длителен, однако в конечном итоге дает целостное и всестороннее представление об исследуемой медицинской технологии, что в свою очередь позволит правильно внедрить ее в клиническую практику и систему здравоохранения.

In recent years health care professionals came to understanding that any medical technology should be a subjected of expert evaluation. One of the key issues in the evaluationt of medical technologies is the ability to transfer effectiveness data to efficacy. Effectiveness and efficacy are also a part of translational (operational) research, transferring from basic knowledge to clinical practice. Effectiveness and efficacy studies, as well as translational research usually allow to evaluate the reasonability of the use of medical technology in a defined group of population in terms of clinical outcomes and costs. The problem of fragmented biomedical data can be solved by means of conducting translational (operational) research in which medical technology is evaluated from the perspective of fundamental science. The translation process takes quite a long time, but eventually gives a holistic and comprehensive idea about the investigational medical technology, which will allow its correct implementation into clinical practice and health care system.

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The authors declare that there are no conflicts of interest present.