You don’t say! Packed with eager, treatment naive participants, and short of the many transportation complexities faced in little established research sites, Eastern Europe is becoming increasingly recognised as among the best places to conduct a clinical trial. The surprise is just how long the pharmaceutical industry has taken to see it!
A recent survey of pharmaceutical executives conducted by the International Quality and Productivity Centre (IQPC) found that Eastern Europe is standing out to pharmaceutical executives against the more established locations for clinical trials, such as North America and Western Europe.
Two major reasons why Eastern Europe is increasingly being chosen as a research site lie in the people – the willing patients and highly experienced researchers.
Francisco Vega, PhD and VP of study start-up and global clinical operations at inVentiv Health Clinical UK, explained that the stringent training requirements demanded in Russia, where principal investigators must have demonstrated five years of experience contributing to clinical trials, also exist in many Eastern Europe countries.
Stanislaw Mosiej, clinical development operations and EEMEA regional head at Roche, said that the investigator teams are “excellent contributors” because they reliably provide quality data on time.
The Eastern European public tends to be much more willing to enrol in a clinical trial than people from more Westernised areas, including Western Europe and North America, because standard care in the region offers them fewer and less effective treatments. Biosimilars are especially sought after because the patented drugs are hard to access.
The populations are also largely treatment naïve and ethnically homogenous, which facilitates the assessment of treatments with pharmacokinetics that vary with the patients’ genome.
The organisation of healthcare within Eastern Europe channels patients into a small number of specialist centres, from which many patients who fit protocol criteria can be selected and treated at the same site.
Comparing Eastern European countries
When considering where to conduct a clinical trial, countries can be functionally divided by their adherence to EMA guidelines. Opting for an EMA-signatory country, such as Poland, Czech Republic, Lithuania or Romania, gives you easy transport of drugs into and out of the countries.
Some pharmaceutical companies are concerned that political conflict in the Ukraine and Russia could disrupt the transport of drugs and other items needed during clinical research. However, scientists working in the region have said that the transport difficulties are limited to areas of conflict.”
Another factor helpful to consider when selecting trial location is how quickly requests to conduct clinical trials are approved. These decisions are usually made within 60 calendar days in the EU, which is faster than in Eastern Europe and Russia, where approvals takes 60 working days plus extra pauses (totalling 3-4 months).
Non-EMA-signatory countries: added considerations
If you choose to work in a country that does not follow the EMA guidelines, bureaucracy can be limited by selecting a nation that will issue a blanket import license for all shipments of the investigational product rather than require individual import license for every shipment, according to a report in lifescienceleader.com.
Robert Arbeit, M.D., VP of clinical development at Idera Pharmaceuticals, told lifescienceleader.com that he recommends firstly establishing a depot inside the EU. Shipments can then easily be made from the EU depot to EMA-signatory countries outside the EU. If the ‘good distribution practices (GDP)’ outlined by the EMA are not followed by the study’s country, an in-country depot improves flexibility of clinical trial supplies by bypassing the obstacles of multiple import licenses and restocking multiple sites.
GDP depots make drug supply predictable as sponsors can export drugs from such countries for a whole year using a single license, dispense them to trial sites as needed and recover unused drug when the trial ends.
Like most industrial operations, the smooth running of clinical trials – anywhere – comes down to logistics. The wide range of challenges varies by country. A different rail gauge is used in the Ukraine, Russia and Serbia, for instance, warranting inter-car transfer of cargo at their borders. Temperature control of pharmaceutical cargo is hard to find. While Moscow airport has large refrigerated rooms, the conditions can’t be guaranteed.
Merck combats temperature challenges by employing local vendors, lifescienceleader.com claims. Mosiej told the lifescienceleader.com website that he recommends testing the ability of clinical research organisations known for their work in Eastern Europe to perform in smaller countries.
Contractors with close links to the countries in which they work have a vested interest in the study’s success and will most likely take special care of their responsibilities. It is also of huge value to choose partners that speak the local language fluently and understand local clinical trial bureaucracy.
Lifescienceleader.com (Jan 2015). Why Eastern Europe may be the best location for your next clinical trial: http://www.lifescienceleader.com/doc/why-eastern-europe-may-be-the-best-location-for-your-next-clinical-trial-0001?sthash.F74hJox2.mjjo