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Since 1990, the countries in Central and Eastern Europe (CEE) have changed tremendously and have combined to become one of the most dynamic and fast-growing regions in Europe. Both pharmaceutical companies and CROs have positioned themselves in the emerging CEE market, and Premier Research has been one of the first to explore this region and realize its true potential.
Several advantages to conducting clinical studies in this region exist.
The total population of the region exceeds 300 million providing access to a large potential pool of clinical trial subjects. The medical systems in the CEE region remains highly centralized, so that nearly all patients are referred to the major centers. As a result, the centers have patient registers that provide investigators with access patients who can quickly and easily be considered for entry into clinical trials. Therefore, patient recruitment in CEE countries often occurs immediately after study start-up allowing recruitment to frequently be completed well ahead of schedule.
Investigators play a key role in the success of the CEE countries in clinical research. Physicians in CEE have a high level of solid medical training and education at established medical schools and are well qualified for conducting clinical trials. Clinicians are highly motivated to participate in clinical trials in order to attain access to cutting-edge research, which furthers their professional qualifications and enhances their prestige among colleagues.
In many cases, patients in CEE have not benefited from the most recent advances in medicine and view clinical trials as a conduit for the latest medical treatments available. Moreover, there are many patients who have not been exposed to treatment, since fewer pharmaceutical products are on the market. This facilitates the recruitment of patients into clinical trials with fairly strict concomitant medication entry criteria.
Patients in this region also tend to see the same doctor every time they visit the hospital, which builds a trusting relationship between the doctor and the patient. This trust has expedited patient recruitment and translated into high patient compliance and low dropout rates even in long-term trials, resulting in more qualitative data.
Many of the CEE countries have now joined the European Union. Membership in the EU means compliance with fully harmonized legislation that incorporates the European Union Clinical Trials Directives 2001/20 and 2005/28. EU membership also guarantees compliance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. At the same time, the non-member CEE countries have also decided to base their clinical research legislation and guidelines on the EU directives and GCP, and thus comply with the international requirements for conducting clinical trials.
Although the submission process among CEE countries may vary, the process of obtaining regulatory approval can be completed in a timely fashion with careful planning by experienced local regulatory professionals. It typically takes two to four months, depending on location, to complete a parallel submission to the Regulatory Authority and a central Ethics Committee for a single opinion that results in CEE approval.
Compared to Western Europe, the costs of conducting clinical trials in the CEE region have been competitive due to slightly lower investigator fees and expenses for monitoring and traveling. However, investigator grants are becoming more equal to those in Western Europe. Costs in the CEE remain low due to the shorter timelines in patient recruitment, larger number of patients recruited, high quality data and low data query numbers.
The CEE countries usually generate high-quality clinical trial data due to their motivated investigators, good patient compliance, and well-qualified clinical research associates. Measurements of the quality of the data include the typically lower query rate and the positive outcomes of independent audits and regulatory inspections.
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