Investigator Initiated Trials: modern trends
https://doi.org/10.17650/1818-8346-2019-13-4-89-94
Abstract
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.
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.
About the Authors
A. G. Torubarova
Almedis
Russian Federation
Russian Federation
M. B. Nasonova
Almedis
Russian Federation
Russian Federation
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Review
For citations:
Torubarova A.G., Nasonova M.B. Investigator Initiated Trials: modern trends. Oncohematology. 2018;13(4):89-94. (In Russ.) https://doi.org/10.17650/1818-8346-2019-13-4-89-94
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