OncohematologyOncohematologyОнкогематология1818-83462413-4023Publishing House ABV Press32410.17650/1818-8346-2019-13-4-89-94BASIC RESEARCHФУНДАМЕНТАЛЬНЫЕ ИССЛЕДОВАНИЯ В ПРАКТИЧЕСКОЙ МЕДИЦИНЕ НА СОВРЕМЕННОМ ЭТАПЕInvestigator Initiated Trials: modern trendsИсследования, инициированные исследователями: современные тенденцииhttps://orcid.org/0000-0002-0632-0959TorubarovaA. G.ТорубароваА. Г.
Russian Federation

Анна Геннадиевна Торубарова 

119435 Москва, ул. Малая Пироговская, 5

anna.torubarova@almedis.ruhttps://orcid.org/0000-0003-2827-7354NasonovaM. B.НасоноваМ. Б.
Russian Federation

119435 Москва, ул. Малая Пироговская, 5

AlmedisАО «Алмедис»03122018134899402012019020120192018https://oncohematology.abvpress.ru/ongm/article/view/324

Recently, interest in Investigator Initiated Trials (IIT)/Investigator Initiated Studies (IIS) in pharmaceuticals and medicine has increased.The relevance of such trials is due, on the one hand, to increased knowledge of diseases pathogenesis, potential targets for drug exposure, and on the other, the development of technologies, primarily the Internet and computer methods that create opportunities for organizing collaboration, the collection and processing of information. Almost all participants in the process of creating new drugs and treatments – pharmaceutical companies, regulatory authorities, associations of doctors and patients – have realized the importance of supporting IIT and developed mechanisms for this.The purpose of this article is to review new trends in IIT in the world and the possibilities for conducting them in Russia, and also exchange of experience in the development, approval and implementation of international IIT in our country.

В последнее время в мире вырос интерес к исследованиям, инициированным исследователями (Investigator Initiated Trials (IIT), или Investigator Initiated Studies (IIS)), в области фармацевтики и медицины. Актуальность таких исследований обусловлена, с одной стороны, сложившейся ситуацией в медицине и фармацевтике, в том числе ростом знаний о механизмах развития заболеваний, потенциальных мишенях для воздействия лекарственных препаратов, а с другой – развитием технологий, прежде всего Интернета и компьютерных методов, которые создают возможности для организации совместной работы исследователей, сбора и обработки информации. Практически все участники процесса создания новых препаратов и методов лечения – фар-мацевтические компании, регуляторные органы, ассоциации врачей и пациентов – осознают важность IIT и занимаются разработкой и усовершенствованием механизмов поддержки этих исследований.

Цель данной статьи – обзор новых тенденций в IIT в мире и возможностей проведения их в России, а также обмен опытом в разработке, одобрении и проведении международных IIT в нашей стране.

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