For 6 years in the Russian Federation, 178 permits have been issued for the clinical trials of medications for the treatment and prevention of HIV/AIDS. This is seven times more than in the previous six years, from 2006 to 2011, when 25 studies were approved.
While in 2004-2011 international multicenter clinical trials (IMCT) (80.5%) were predominant, then in 2012-2017, 79,8% of all authorizations for HIV/AIDS medication trials regarded bioequivalence studies. Russian sponsors initiated 61.2% (109 in absolute figures) of bioequivalence studies, foreign sponsors initiated another 18.5% (33) studies. Such data was published in the 16-th bulletin of the Association of Clinical Trial Organizations. The Information and Analytical Bulletin is a periodic publication of the ACTO on the dynamics of the Russian clinical trials market, legislative initiatives and innovations and their implications for the clinical studies area.
In addition to the traditional sections, the bulletin included an analysis of the situation with trials of drugs for the treatment of HIV, hepatitis C and tuberculosis. A rough estimate shows that clinical trials for all three nosologies in Russia have a potential to expand in quantity (the number of study permits) and enhance in quality (the availability of the latest developments on the local market).
The number of local studies initiated by Russian companies has grown: for six years, from 2006 to 2011, there were two of them, while in the last six years, 2012-2017, there were already nine, and eight of them focused on researching domestically developed medications. The increased number of local studies may be fostered by the adoption in 2011 of the federal target pharmaceutical industry development program until 2020.