Ukraine's Clinical Trials

In a webinar today, Natalia Fetkovska, MD, PhD, and Senior Partner at SanaClis, a CRO that provides clinical trial services for Central and Eastern Europe (CEE), brought a well-informed update on how the problems in the Ukraine are impacting clinical trials in the region.

The presentation began with highlights of clinical trials market share within in the CEE, reinforcing the area’s reputation for productive and efficient clinical trials. This included facts around the Ukraine, including how its proportion of clinical trials in CEE has grown over the past two years, and lags only behind Poland and Russia—outside of the Baltics—for clinical trials market share of Phase II and III trials at 13.6%, 19%, and 19% respectively.

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

Fetkovska outlined those specific political developments and then delved into their immediate impact on clinical trials.

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. An instruction, however, is not a law. But as Fetkovsa explained, sponsors could ask Russia for study approvals for Crimean sites, however, Russia requires that each site be certified by its own Minister of Health.

The Ukraine parliament also decreased the VAT tax on imported medicines from 20% to 7%. And clinical supplies and IP are continuing to the region for ongoing studies. Fetkovska noted that for SanaClis own shipments from its warehouse, a total of 1,135 between January and May 2014, none were delayed or undelivered.

Fetkovska suggested that while some sponsors have suspended recruitment in Eastern Ukraine, they should still consider all of 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