Eastern Europe's turbulent political climate may mean it would seem an unlikely location to run clinical studies; however recent figures show that Eastern Europe, alongside South America, is currently showing the greatest global growth in clinical trial activities. This recent rise is set to continue, largely being driven by two main factors. Firstly the cost of starting and running trials in the US and Western Europe is considerably more than Eastern European countries such as Romania, Hungary and Russia. Additionally, many ill people in Eastern Europe are unable to afford Western medication, so there is a large pool of untreated patients to enroll, with the added benefits of reduced dropout rates and improved compliance. Capitalizing on this 'untapped' patient population could be a great way to further benefit clinical studies however Eastern Europe, like other emerging markets, comes with a range of obstacles for companies attempting to import drugs into these countries.
Handling Political Objections
Eastern Europe has long been an area of political sensitivity, and this is reflected in the difficulty of importing clinical supplies into places such as Ukraine, Romania and Russia. Even if the countries show a willingness to host trials with a team of eager and compliant investigators, political obstacles can mean the supplies won't even be able to pass the borders. When hoping to import a batch of supplies to a large number of patients, many Eastern European countries require a lengthy explanation as to the purpose of the products and the details of who is being treated. This often leads to pharmaceutical companies facing costly delays to trial start-ups, despite having the site and patients sourced. Often traditional benefits surrounding drug studies fall on deaf ears as officials fear their political image will be damaged if they are to be seen as a large scale clinical trial site for sick patients. What's more, standard EU regulations are adapted differently by countries within the continent, particularly in Eastern Europe, so unfortunately paperwork used for Western countries isn't likely to meet with Eastern European regulations. Many pharmaceutical or contracted companies are working around these difficulties by encouraging more open communication between drug companies and local authorities as to the nature of the study. Many sponsors currently transporting supplies into Eastern Europe recommend seeking assistance from local or experienced international service providers to gain advice on how the regulations are best adhered to, and to overcome cultural barriers. This flow of information could help greatly reduce the time supplies spend crossing borders.
In-depth Planning
Aside from political objections, Eastern Europe is a place most sponsor companies will have little knowledge of internal transport links once their drugs have crossed the borders. Even before trials have begun, there are a number of steps that need to be taken to ensure imported drugs aren't at risk from delays. Eastern Europe is well known for some extreme temperature conditions, particularly in Russia, and this could easily lead to excursions both at depots and during transit if these are not accounted for. To avoid this, meticulous planning and research into sites should be carried out well before to avoid major delays. Notably, gathering the necessary information regarding depots can also delay timelines even if the patients are enrolled, so these steps should be taken well in advance. Many international service providers advise on an in-depth knowledge of local road and rail links too, as these can often change when travelling across several borders. All these factors must be calculated before your supplies reach the patients, or you risk not having the right amount of supplies to move forward with your trials. Finally, the possibility of an ongoing supply network into Eastern European countries should be evaluated. Many countries such as Russia require individual import licenses for each drug, meaning previous studies won't necessarily mean a speedier importation process the second time round. As with all clinical operations, advanced planning remains one of the most important factors in ensuring the speedy transportation of supplies within Eastern Europe.
The Triangle Partnership
By offering a degree of study control to local investigators, foreign companies will help gain the trust of the communities and overcome cultural issues. But just as there is a need for open communication with border authorities and local officials, many companies with success in Eastern Europe stress further steps should be taken to ensure a strong relationship between the trial sponsor; the CRO and the clinical supplies provider directly involved in the trials. Good working relationships between sponsors and vendors is always crucial to the success of a trial, but perhaps even more so in an area such as Eastern Europe which has been proven to have particularly challenging external regulations. This 3-way cooperation will allow for group consultation and advice on local regulations and customs that could prove invaluable for avoiding timeline delays. Through this open partnership, as well as knowledge gained from local officials, both trial sites and clinical supply teams will benefit from maintaining regulation compliance across clinical operations. Frequent communication and cooperation within the 'triangle' is key in such a challenging region.
Conclusions
Eastern Europe is a challenging site for clinical supplies, yet it also remains an area of the world with the most potential for furthering clinical studies. Many hospitals and clinics have the necessary personnel and patients to run the studies, but have not yet had access to study drugs outside of Eastern Europe, and so are unable to go ahead with trials. One alternative is the local sourcing of supplies from within Eastern European countries. Whilst this can ease some of the issues at borders and save on timelines, it will not be possible to acquire all types of drugs, and in large enough quantities. When importing drugs from outside, a cautious approach to Eastern Europe is needed to ensure political objections can be handled, whilst not hindering the movement of supplies across borders. Once inside the countries, prior planning becomes important to ensure extreme conditions and irregular transport networks don't cause delays. Finally, a close relationship between the trial sponsor, the clinical supply partner and local authorities will ensure a healthy supply chain can be maintained throughout the trials.
