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There is currently an increasing number of requests from sponsors for accelerated recruitment times in clinical trials without reducing quality, and with optimal cost-efficiency. To meet these expectations, pharmaceutical companies and CROs are setting up a growing number of clinical trials in central and eastern Europe (CEE). The need for data quality and cost-efficiency has led to the regular evaluation of clinical research performance and the capacity of CEE investigational sites. Several factors have contributed to the significant increase in the number of clinical trials conducted in CEE over the past few years (1). Although reports available in the Literature have used different methods in the assessment of levels of quality and benchmarking in clinical trials, there is evidence that the contribution in terms of sample size, the quality of the data obtained, the ethical care and the compliance with good clinical practice (GCP) guidelines in CEE sites is generally higher than that obtained in Western regions, including the US.
MULTINATIONAL CLINICAL TRIALS: THE PUBLISHED CEE EXPERIENCE
Conducting pan-European clinical trials, possibly also involving countries outside of Europe, allows the comparison of key performance indicators (speed, quantity and data quality) across CEE and western European countries in the same trial.
The results from a trial conducted in 11 countries (five in CEE and six in western Europe) have shown that CEE countries recruited more subjects than originally planned and were available for a prolongation of enrolment in replacement of low recruiting countries. In addition, sites in CEE countries had fewer queries than those in western Europe (see Figure 1) (1). |
