Arena International recently held its 5th Annual Outsourcing in Clinical Trials Canada conference on the 28th & 29th October 2015 in Montreal. With the Montreal biotech space seeing resurgence in recent times, this event brought together clinical trial experts from both pharma and biotech’s across Canada to explore strategies to help overcome reoccurring challenges while outsourcing clinical trials.
Many different topics were covered during this exciting event but most notably, Chief Development Officer and clinical trial expert Patrick Colin of Verlyx Pharma touched upon a subject that caused the most intrigue. His presentation delved into the lucrative opportunities available for the Canadian biopharmaceutical market to conduct clinical trials in Central and Eastern Europe.
For many Eastern Europe would not be their first choice to carry out clinical trials with such political instability, impractical visitation and difficult language barrier. However Patrick went on to show the advantages of carrying out clinical trials in Eastern Europe, paticuarlarly highlighting the bigger patient pool and significant cost differences.
With 80,000 clinical studies taking place in North America alone and 80% of those facing delays mostly due to poor patient recruitment, Patrick put this down to crowded therapeutic areas and the increasing complexity of clinical trials. Therefore, it is no wonder that pharma companies are starting to look at Central Eastern Europe (CEE) as an alternative location.
As someone with many years of experience of carrying out successful clinical studies in that region, Patrick highlighted Poland as the ideal location within the CEE area. Poland is currently the largest country within Central Eastern Europe with a population of 38 million, a similar demographic to both Western Europe and North America.
Poland does appear the ideal location for clinical trials within the CEE area, especially considering the cut price cost of clinical trials. There is also much easier access to patients, with willing participants eager for access to better healthcare and new promising therapies.
As often brought up by clinicians, the fear of poor quality data is one of the biggest red marks pharma and biopharma companies put against Eastern Europe, especially given the lack of oversight available. What seems apparent is that a clear and trusting relationship is required with your CRO in order to maintain the expectation for high quality data.
A complicated regulatory landscape can often act as a deterrent for carrying out clinical trials in that area. Fortunately, Poland has a clear and straight forward regulatory landscape. Being part of the EU since 2004, the country follows the same EU directive on clinical trials as Western Europe.
An integral part of a successful clinical trial is the partnership between sponsor and CRO, a factor that is even more important when carrying out clinical trials in CEE. Patrick pointed out some required strengths your CRO must possess, two of which stood out in particular; extensive knowledge of the clinical market in Poland and a long history of delivering high quality services at site level. However, it would be wrong to diminish the importance of other key strengths, such as a good reputation and a good relationship with the regulatory authority.
Patrick concluded his presentation by comparing both CEE sites with Canadian sites, outlining the pros and cons. The pros of using a CEE site included greater access to patients, quick enrollment, a sound regulatory structure, and – arguably one of the biggest factors in its favor – low costs. Nevertheless the disadvantages of using a CEE site cannot be ignored either. As can be expected in an unfamiliar market there are always going to be cultural differences, language barriers and the impractical challenge of visiting sites that are long distances away.
Despite Central Eastern Europe being considered as an emerging market for furthering clinical trials, one cannot hide that it remains an area that presents challenges and carries risks for many biopharmaceutical companies. The decision to delve into the CEE area is a difficult one and for many it will depend on key internal factors, such as the budget the company is working with and the indication of drugs being developed.