The Contract Research Organization Perspective: Audits in Central and Eastern European Countries

Abstract

Pharmaceutical companies are now looking more to increasing numbers of Eastern European countries to conduct clinical studies. Various advantages accrue from these countries, notably cheaper cost and naive patient populations. However, there is the danger of false economy with cheaper meaning poorer quality. Published results appear contradictory, with some confirming more major Good Clinical Practices violations in Eastern Europe than in Western Europe, while others suggest the reverse. Experience when conducting audits carried out in Eastern Europe has revealed that problems do exist. Many of the problems lie with the failure of the sponsor companies to provide adequate training for both monitors and investigators. Commitment by investigators in Eastern Europe is high and a small amount of time and finance invested in training could be rapidly repaid through high-quality studies.