Clinical trials in Central and Eastern Europe

In great multi-national studies it is usual that CEE countries are 2-4 months ahead of patient recruitment schedule. Many US companies are initiating rescue projects in CEE if the patient recruitment of their ongoing US-based or Western European trial fails to meet the requirements/goals. The great recruitment performance of the CEE countries is maintained by many factors: wide availability of naive (untreated) patients, lack of, or insufficient availability of, preventive medicine, shortage of available therapy. Although all CEE countries have adopted European (EU) guidelines, the reality forces physicians to use what is available rather than what is recommended by recent science. Patient willingness to participate in clinical trials sponsored by US companies is also an important factor.

There is an abundance of high quality investigational sites in South Eastern Europe because the number of teaching hospitals, university clinics and postgraduate medical schools is high. More practitioners are employed by teaching hospitals and university clinics than in Western Europe. GCP guidelines are fully implemented (GCP training of the investigators is required by the regulatory authority.) As the result of high scientific standards, FDA inspections reported fewer findings of violations in CEE trial sites than in Western European counterparts.

Both the investigator and monitoring fees of a clinical trial in CEE are significantly lower than those in the US or Western Europe. The monitoring costs are 60 – 70 % of the US prices while the investigator and hospital fees almost never reach the 70 % of the US level. The additional costs, such as travel, accommodation and postage are also significantly lower.

Because of the great development experienced in the past decade, many physicians and pharmacists are willing to work in the pharmaceutical industry, using their expertise in clinical research as CRAs or project managers. The highly regarded academic and industrial training programs of the CEE region produce a valuable human resource pool for research professionals.