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Clinical Trials in Central and Eastern Europe become the global advantage

Clinical Trials in Central and Eastern Europe become the global advantage

Publish date: 2012-04-09

Newly developed drugs must be controlled in terms of efficiency and safety. At this step clinical trials are inevitable. They account for the biggest and also the longest part of total cost connected with introduction of new pharmaceuticals to the market. It is estimated that the global market of clinical trials is worth approx. 50-80 USD, depending on the reference, and its value is still growing. This increasing trend is predicted to last especially in the most business attractive regions, such as Central and Eastern Europe (CEE).

Tags: medicine , pharma , interview , russia

The typical process of clinical trials includes 3 up to 4 phases which in total last for approx. 8 years. The longest and the most expensive part of the trials is phase 3 devoted to definitive confirmation of a drug’s efficiency. Both phases 2 and 3 require recruitment of patients, however, in case of the 3rd phase their number is several times greater and often accounts for even thousands of individuals. Large quantity of volunteering patients eager to participate in medical trials is not easy to achieve in countries with strongly developed public health care.

There are several subjects involved in development of new pharmaceuticals apart from the obvious patients and research institutions accompanied by pharmaceutical companies. Undeniable high expenses of clinical trials entail presence of effective sponsors. As effectiveness depends on the level of interest in prosperity of a new drug, pharmaceutical companies sponsor their new inventions the most often. Of course, clinical trials constitute only a part of the total cost needed to implement a pharmaceutical novelty into the market, therefore, cost effectiveness is what entrepreneurs are looking for nowadays.

Increased effectiveness is observed also due to outsourcing of services. In case of clinical trials, Contract Research Organizations (CROs) play the key role as the main contractors of drug companies, which are focused on organization and attendance of the drug assessment. CRO cooperate with Clinical Research Associates (CRAs), who is responsible for qualified monitoring of the research process. As presented by the PricewaterhosueCoopers (PwC) Poland in the most recent report on clinical trials, CROs are involved in around 70 % of total clinical research in terms of quantity and over 50 % in terms of value.

As it is claimed by experts, the most important issues to be improved to support and accelerate development of the global clinical trials business sector is cost-effectiveness connected with expansion of new promising markets. CEE is found advantageous over others especially in terms of easiness in patients’ recruitment and relatively low costs of the total process, which attracts many technologically developed investors from Western Europe (WE) and the USA.

But it is not only about low cost and amount of volunteers. Central-European clinical investigators are known worldwide as well trained, reliable and working for substantial results.

We had a chance to obtain a valuable comment on the present situation of clinical trials in CEE from the Eastern-European company, OCT CRO*, providing full-scale services in clinical research. Ms Natalia Salamova, the Business Development Manager, posted some comments from the OCT’s point of view. Considering rapid development of European clinical trials - “most of our clients and sponsors are companies coming from either WE or the USA but we also can observe a constant increase in the number of Russian and CIS sponsors. I would not say that there are a lot of sponsors exactly from the countries, where we operate, which include mainly Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria . To a high degree, our customers are from western countries (Germany, Switzerland, the UK, Italy, etc. and also the USA).” (…) An ever-increasing number of Russian companies may to a certain extent be also explained by the favorable legislative conditions. There has been a boom in the Russian pharma industry. There are a lot of start-up biotech pharmaceutical companies, which produce original as well as generic drugs. Naturally, before entering the market, these drugs have to be tested and their safety and effectiveness analyzed, the process being strictly controlled by the competent regulatory authorities (the Ministry of Health and Social Development of the Russian Federation). To encompass all the needed activities, companies address OCT to assist them in this essential matter

Surely, one could name some key advantages of the CEE market, which make it particularly interesting. “Among the financial ones we could name the following” – says Ms. Salamova – the overall costs. We could say that the overall cost for conducting clinical trials in Russia, Ukraine and Belarus would be less as compared to those in the  USA or WE (however, surely depending on a therapeutic area and the scope and design of the study). What factors stipulate this?

For instance, principle investigator’s grants are usually lower than those in the USA and WE, and this is also connected with the fact that, generally speaking, this way physicians can gain additional source of payment. Yet, naturally, this is not the prime reason. Important is also that the investigators participating in clinical trials have an access to new therapies, latest, up-to-date drugs. At the same time, patients are eager to participate in clinical trials because of the access to these new drugs. It is also connected with the fact that there are a lot of patients in this region that have not yet been exposed to new drugs. This enables researchers to include patients into the trials.

Another thing is the timelines, which influence the general price as well as the pace of the trial. This is also one of the key strategic factors for sponsors. Timelines for RA approval and patients` enrollment (which sometimes turns into a crucial point) are quite favourable in this region.

The choice of analyzing laboratories, warehouses and other vendors is pretty extensive. The pharmaceutical industry has been booming in these countries during the last 5-10 years, which imposed other service providers to deal their businesses. It constantly gives us more and more options. Even speaking about the number of clinical trials compared to those from the last year it has grown, especially in case of phase 3 and 4 trials,” – clarifies Ms. Salamova.

Apparently, pros of the CEE clinical trials are quite uniform among different countries. Large pharma companies, such as GSK, AstraZeneca, BMS and Roche are only examples of sponsors interested in running clinical research in this region. For instance, Poland appears to be a target market to conduct clinical trials of over 80 % of all new drugs in the world (as well as 20 % of total research in the CEE region). Great number of inhabitants attracts trials demanding large number of volunteers. What is more and not that optimistic, patients in CEE are regarded as very valuable in scientific sense, as they often present advanced phase of a conditions, such as cancer or cardiac malfunctions, which is directly connected with limited access to latest inventions in medicine as a rule. Luckily, increased investment in clinical trials will naturally entail development of public service favoring situation of the CEE patients. At the same time, rapid development of medical care will cause loss of interest in volunteering among clinical trials, which could affect further development of this business sector negatively. Such situation is predicted to implement in several decades. This is why experienced and reliable investigating institutions in CEE, which are only predicted to improve the quality of their services in time, remain the most important advantage of the market.

Of course, there is always the other side of the coin, where things get a bit less optimistic. There are several issues creating a barrier against further development of clinical trials in CEE, which must be removed as fast as possible. Most bothering ones are long administrative procedures consuming up to 30 % of the countries budget. Clarification of the regulatory environment could definitely bring significant amount of savings to the societies of CEE. What is more, most of the patient associations recognize a need to educate societies more effectively and to improve the information-flow in terms of clinical trials and accompanying benefits. It should be for greater focus on motivation aspects towards both, patients and researchers.

The Russian market of clinical research recognizes a bit different and unusual barrier in the development - “One of the existing complexities is connected with generic drugs. For generic drugs, companies still have to repeat the earlier-conducted trials (bioequivalence) in Russia, as well. .   Foreign Companies have to organize additional money for an additional trial to register their generic drug. This is how it works now.” – says Natalia.

Regardless of all the actual cons CEE remains an extremely interesting region for development of clinical trials. Further investments and cooperation to improve the quality of services will lead to development of better business quality of global meaning. Pharma corporations must stay interested in the CEE market if they want their drugs to be successfully implemented in the health care routine.

 

*OCT - a full-service Contract Research Organization operating in Central and Eastern Europe (CEE), established in 2005. With offices in Russia, Ukraine, Belarus, the Baltic States and Bulgaria, and more than 90 clinical research professionals across CEE. OCT provides high-quality and cost- effective services to pharmaceutical, biotechnology and medical device companies. More at: http://www.oct-clinicaltrials.com

Sources: authorized interview; http://www.gcppl.org.pl/

Anna Drzazga

 

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