The Contract Research Organization Perspective: Audits in Central and Eastern European Countries
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0092-8615/2001 Copyright 0 200 I Drug Information Association Inc.
THE CONTRACT RESEARCH ORGANIZATION PERSPECTIVE: AUDITS IN CENTRAL AND EASTERN EUROPEAN COUNTRIES HAROLDNEAL,PHD GCP Auditing Services. Farnborough, England
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 nai've patient populations. However, there is the danger of false economy with cheaper meaning poorer qualig. Published results appear contradictory, with some confirming more nlajor 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 nith 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 andjnnnce invested in training could be rapidly repaid through high-quality studies. Key Words: Audits; Central and Eastern Europe
COMPETITIVE PRESSURES WITHIN the pharmaceutical industry mean that companies are constantly trying to shorten the drug development time to bring new products to the marketplace. It is also beneficial if this shorter time can also be achieved at a lower cost. With this in mind, there has been a trend for pharmaceutical companies to look at locations away from the traditional areas of the United States and Europe to conduct clinical trials. Generally, this has been for the larger Phase 111 studies. One geographical area that has been perceived as fulfilling the necessary criteria is Central and Eastern Europe. In the past there has been an apparent Presented at the DIA 36th Annual Meeting, June 1115, 2000, San Diego, California. Reprint address: Harold Neal, PhD, GCP Auditing Services. 14 Reading Road, Farnborough, Hampshire GU 14 6NA, England.
reluctance to conduct trials in these Eastern European countries, possibly based upon perceptions that the economic standards within the countries were not high and, therefore, clinical standards would similarly not reach required levels. The political climates in these countries could also have been a consideration. However, these perceptions appear to be changing and there has been a gradual increase in the number of countries in this region where clinical studies have been carried out. A similar increase has also been seen in the number of sponsor companies working in these countries. At the forefront the countries likely to be involved were Poland, Hungary, and the Czech Republic but as companies became more comfortable in placing studies the net extended to include, among others, the Baltic States of Latvia, Lithuania. and Estonia; Bulgaria; Romania; and Russia. Some studies were conducted in
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Harold Neal
the former Yugoslavia and have conti
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