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European Pharmaceutical Contractor

Look East

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).


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Simona Colazzo is Head of Quality Assurance for CROM srl. Simona joined CROM in 2003 and managed national and international clinical trials in several therapeutic areas as Clinical Research Coordinator. She then focused on quality assurance management and since then has completed many national and international courses on quality assurance, and has undergone training by a certified quality assurance company. Simona is now responsible for the supervision and management of the quality system unit activities.

Luca Cantini is the Medical Leader of CROM srl. His background includes 12 years’ experience in a major pharmaceutical company where, as Head of Corporate Clinical Research, he was responsible for national and international clinical trials in a variety of therapeutic areas. From 1990 to date he published several scientific articles and he is certified as a medical writer by major multinational companies. Luca is now a consultant in clinical research and development with experience in project management and expertise in medical writing.

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Simona Colazzo
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Luca Cantini
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