Analysis by the Moscow, Russia-based contractor Synergy Research Group reveals that 108 of the 155 trials approved in Ukraine in the first half of 2014 were part of multinational, multi-centre clinical trials (MMCT), which is up from the 93 approved last year.
According to the data, US contract research organisation (CRO) Quintiles conducted the most MMCTs in Ukraine last year ahead of PPD, though its InnoPharm subsidiary, and Switzerland’s PSI CRO AG and the regional divisions of Janssen and GSK.
The study also lists Icon, Parexel and INC research among the most active clinical trial applicants in 2013.
Synergy Research Group, did not provide data for H1 2014, however, CEO Igor Stefanov told Outsourcing-pharma.com the higher number of MMCT approvals reflects an increase in the number of applications submitted by foreign CROs and sponsors.
Another driver, according to Stefanov, were improvements to the regulatory framework through Ukrainian MoH order #304, which outlined new rules on liability insurance and collecting participant oral histories, and order #396, which set out the guidelines for bioequivalence studies.
The positive impact of the two orders echoes that of laws introduced in 2012 , which simplified the process of importing clinical trials supplies into Ukraine and prompted a surge in applications Stefanov said.
"The current situation in Ukraine is favorable for clinical trials conduct. Contributing factors to this favorable environment include country population, a well-developed and structured system of healthcare, highly qualified stuff and a growing number of experienced investigative sites that contribute to the rapid recruitment of patients."
Crimea conflict
The increase in trial approvals and applications by international firms comes despite ongoing political and military conflict in Ukraine between pro-European and pro-Russian factions and follows the annexation of Crimea by Russia in April.
The confusion over the regulation of clinical trials in Crimea is emblematic of the wider Ukrainian pro-Europe versus pro-Russia debate.
On May 12, the Ukrainian Minister of Health said no new clinical trials would be approved in either Crimea or Sevastopol and that all ongoing studies should halt recruitment.
However, as the region is now controlled by Russia, contract research organisations (CROs) and sponsors seeking to conduct trials there have been able to ask Moscow authorities for the right to conduct studies, provided the sites were already approved by the Ministry of Health.
This point was underlined by Stefanov, who told us: “Crimea is not a Ukrainian territory anymore, so it isn’t a subject of Ukrainian MoH regulation.”