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Global Pharma Identifying Quality Challenges with Russian Clinical Research Sites


The PharmaLetter reports that multinational biopharma companies are not happy with clinical investigator sites in Russia.  The sponsors report challenges including:

  • Lack of research experience
  • Weak infrastructure
  • Inefficient Sponsor support
  • Undeveloped protocols

Troubling news given Russia of late has tightened requirements up for local clinical trials research based reports The Pharma Letter’s local correspondent.   Russia has sought out to comply with international standards such as GxP.  This resulted in a clinical research manual centering on clinical studies within the territory of the Eurasian Economic Commission (EEC)—an body of the countries of the Eurasian Economic Space (includes Russia, Belarus, Kazakhstan, and other former Soviet states).

TrialSite News reviewed other reports.   For example the New England Journal of Medicine provided “smoking gun” evidence of regionally inconsistent clinical trial data highlighting the TOPCAT trial example. CardioBrief noted that global clinical trials involve data integrity issues, “in particular from  Russia and other countries from the former Soviet Union.”  On the TOPCAT trial Science Magazinecommentator Derek Lowe noted “So if you’re thinking of running a big clinical trial in Russia or perhaps one of the former Soviet republics, you might want to consider the example of TOPCAT.”  Lowe noted that it isn’t just Russia and that he had worked with a great number of Russian scientists but that we was sad for Russia’s reputation based on the data outcomes.

Among other actions, Russia may benefit from research site accreditation of the type TrialSite News has advocated such as the Alliance for Clinical Research & Safety (ACRES) Site Accreditation & Standards Institute.


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