Ukraine: Still Open for Clinical Trials

June 10, 2014
Guest Blogger

Pharmaceutical Executive

The recent geopolitical developments in Ukraine have seriously influenced the conditions and the environment for clinical trials in Ukraine and in Russia.

The recent geopolitical developments in Ukraine have seriously influenced the conditions and the environment for clinical trials in Ukraine and in Russia.

In a webinar today, Natalia Fetkovska, Senior Partner at SanaClis, a CRO providing clinical trial services for Central and Eastern Europe (CEE), highlighted the problems.

Ukraine’s proportion of CEE clinical trials has grown over the past two years and now lags only behind Poland and Russia. But on May 12, the Ukraine Minister of Health instructed that no new studies would be approved for Crimea or Sevastopol (a city on the Crimean peninsula, with separate municipal powers from Crimea) and that recruitment of new patients into current studies should also cease.

Fetkovska suggested however that while some sponsors have suspended recruitment in Eastern Ukraine, they should still consider Ukraine for their trials. She noted that the investigator and patient population was more than willing to participate in clinical trials because they are feeling the economic impact of sanctions.

To minimize risks for conducting trials in the Ukraine, Fetkovska recommended:
• Avoid Crimea for new studies.
• Avoid sites in the critical cities of Eastern Ukraine, such as Luhansk, and Donetsk.
• Check logistic partners to make sure they are not sanctioned.
• Check site payments to make sure the banks are not sanctioned.
• Check the IT reliability of local partners, cloud-based solutions could or could not be positive based on regulatory concerns.

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