Central and Eastern Europe: an attractive and promising location for clinical trials

One of the greatest advantages of carrying out a study in Central and Eastern Europeis the benefit of cost saving with no loss of quality of service. HungaroTrial, a CRO company, claims that the costs of monitoringa clinical trial are roughly only 60-70% of those which it would incur with a comparable study in the US. Salaries and investigation fees are still lower in the CEE than in Western Europe and the US, and because of the low salaries of doctors it is quite easy to take on qualified medical staff.

Furthermore, because of its large population and the small number of patients who have access to innovative therapies, recruitment for a clinical trial in the CEE region is usually faster than it is in other countries.

According to companies operating on the market whose representatives spoke at the conferences, clinical trials carried out in the CEE region are superior to those carried out in the Western European countries and the US, because clinical trials in the countries of the region are less widespread and because investigators and patients are more motivated. This is also supported by inspections carried out in the CEE area by the US Food and Drug Administration, which showed that, between 1994 and 2008, only 2% of trials in CEE required obligatory measures in order to rectify inaccuracies (in Western Europe the figure was 6% during the relevant period).

A company carrying out clinical trials in the CEE region may encounter ethical problems. This was emphasised by many speakers at the conferences. As such countries have weaker democratic traditions, because of their past political situations, their professional traditions may not be as ethical as those of Western Europe.

Because of this, several problems may arise:

· the reporting of activities which have not been carried out (employees)

· having two conflicting jobs despite a non-competition agreement (employees)

· personal relationships instead of skills used as recruitment criteria (CROs)

· service provider selection not transparent (regional sponsors)

· hiding income and evading taxes (sites)

· corruption.

Although the CEE countries are similar to each other in terms of costs and the quality of trials, there are some important differences. For example, in Russia and Ukraine customs processes are long, complicated and very costly in comparison with the situation in other CEE countries. In addition, many unforeseen procedures may arise in these two countries, and the instigation of a trial is slower and less predictable than in other countries of the region. On the other hand, although Russia and Ukraine are not EU members, they adhere to most EU regulations. Patient recruitment is even faster than in other countries in the region, because of the widespread willingness of patients to take part in a clinical trial.

Furthermore, financial reward plays an important role on those emerging markets with less well-developed economies and health care systems, such as Russia, Ukraine and Bulgaria, but it is not as important in, for example, Poland and Hungary. In addition, the international prestige of an employer might be considered an important motivational tool in Russia or Ukraine, but not necessarily in other CEE countries.

In 2008 there were 468 new clinical trials approved in Poland, in comparison with 449 in 2007 and 451 in 2006. The most widely discussed topic in the country in the area of clinical trials in the recent past was the possibility of adopting a new law which would provide a comprehensive legislative framework for clinical research. At present this area in Poland is regulated by several legal instruments, in pharmaceutical and civil law. The draft version of a new law was presented by the Health Ministry in mid-December, and the public consultation stage is to last until the beginning of January.

The law will change the current regulations pertaining to the insurance of a researcher and will limit the number of clinical studies lead by one researcher (this will be decided individually in each case by bioethics committees). Access to clinical trials is also to be easier. Sites which carry out clinical trials will have to announce this fact on their websites, with any patient, rather than just one chosen by a researcher, able to take part in a trial.

The Head of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), and not the health minister, will issue the final decision on the approval or rejection of a clinical trial, if the law comes into force.

In 2008, 615 new clinical trials were approved by RosZdravNadzor[2] in Russia, representing an increase in excess of 9% in the number of studies in comparison with 2007. In every quarter of 2009, however, the number of new clinical trials approved in Russia fell in comparison with the corresponding period of 2008. There was a decline of around 13% in Q1 2009, 26% in Q2 2009 and around 10% in Q3 2009, according to the Synergy Research Group. In total, therefore, the number of new trials approved fell by 17% in the first three quarters of 2009 in comparison with the corresponding period of 2008, from 474 to 395. This is probably a result of new strategies approved by many global pharmaceutical manufacturers, which decided to limit their spending on research and development during the economic crisis.

Close to half of the new clinical studies approved in Russia during the first nine months of 2009 were phase III trials. Only 6% of new trials are phase I.

The clinical trials market in Russia is dominated by foreign companies. In Q3 2009, 67% of new clinical trials approved were sponsored by international companies. Furthermore, during the period analysed, as many as 61% of new approved clinical trials were multinational and multi-centre, and, despite the general reduction in the number of new trials approved, the proportion of multinational studies increased in Q3 2009 by 3 p.p. in comparison with Q3 2008. Leading international study sponsors in Russia in Q3 2009 included Novartis, Novo Nordisk, GlaxoSmithKline, Merck&Co. and EliLilly.

In 2008 some 61 new applications for clinical trial authorisation and 293 clinical trial notifications were submitted to the State Institute of Drug Control (SUKL) in the Czech Republic. There was a reduction of around 15% in the number of applications for approval/notification of a clinical trial in comparison with 2007. This could be because of a new Act on Pharmaceuticals which came into force in December 2007. This significantly changes the clinical trials arena in the Czech Republic. These are now governed not only by pharmaceutical law, but also by an Administrative Code. This has led to a major increase in the administrative work associated with the assessment of a clinical trial. Furthermore, given the planned changes in the reimbursement of clinical trial costs, companies have decided to speed up their clinical trial applications. As a result, some 60 new applications were submitted in December 2007 alone, twice the usual monthly average.

An application for the authorisation of a clinical trial is submitted for any clinical trial in which the relevant medicinal product is obtained by biotechnological processing or which contains substances of human or animal origin not authorised in the Czech Republic or in the other EU Member States (regardless of whether or not they are authorised in third jurisdictions). Clinical trial notification is granted for, among other things, a medicinal product obtained by means of biotechnological processing and substances of human or animal origin authorised in the Czech Republic or in the European Union states by means of a centralised procedure but which is not used within the scope of the marketing authorisation decision.

Most of the clinical trial applications assessed by the SUKL in 2008 pertained to phase III trials (around 66% of the total) and bioequivalence studies. The most substantial number of applications for approval/notification of a clinical trial submitted in 2008 were in the areas of oncology (20% of the total) and neurology (13%).

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