Chiltern looks east for clinical trials

Chiltern International, one of Europe's leading mid-sized contract research organisations, has opened up an office in Ukraine to tap into a growing market for clinical trial services in central and Eastern Europe.

Dr Faiz Kermani told DrugResearcher.com that the market for clinical research in the CEE region is growing at around 30 per cent a year, driven by very good patient recruitment rates and a large, receptive population base estimated at around 260 million people. The Ukraine in particular is a good market for CROs, he added, as it is characterised by specialist referral centres servicing a large number of people.

In addition, the region is characterised by certain other characteristics that present opportunities that are hard to find elsewhere. For example, if its is important to have patients in a trial that have not been exposed to a particular drug, it is often easier to find them in the CEE. Sadly, the legacy of the Chernobyl nuclear accident and polluting industries mean that some diseases, and particularly some childhood cancers, are more common in the CEE than elsewhere in the world.

In one study carried out by Chiltern, five Ukrainian sites had recruited over 100 patients at the six-month timepoint, compared with only ten enrolled at five UK sites over 14 months.

Dr Kermani said that more and more Western companies have been looking to Eastern Europe to conduct studies. From just 25 studies conducted in the Ukraine in 1999, 2002 saw a four-fold increase to 100, according to data compiled by Boris Golubtsov, a Ukrainian by birth and Chiltern's clinical development manager for CEE.

The shift east has been helped by the widescale adoption of Good Clinical Practice by centres in the CEE, and Ukraine has been at the forefront of this effort, mandating GCP not only at the level of the Department of Health but also as part of state legislation.

All CEE countries are currently considered to be GCP-compliant and this is encouraging sponsors to start large-scale trials in the region, said Dr Kermani.