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scribing and reviewing transcribed data. Validating at source, patient demography, test selection and visit structure will reduce the time spent on checking at later stages of report compilation, thus reducing the time needed to prepare data for statistical analysis. As indicated by Odel [2] 3050% of all data resolution queries (DRQs) concern laboratory data. Since some DRQs may take up to 80 days to resolve, remote data entry and electronic data transfer can have a significant impact on reporting time. |
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D. Establishing Central Laboratories in Europe |
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Central clinical pathology laboratory testing was once dismissed as unworkable in Europe. Strict border controls, combined with enormous cost and grave logistical difficulties of transporting specimens across a continent, were regarded as insurmountable problems. A concept that was embraced by U.S. trial organizers in the mid- 1980s was considered inappropriate for a continent as linguistically, politically, and culturally diverse as Europe. It is only in the past 3 to 4 years that we have seen companies like SciCor, SmithKline Beecham, and Medinet establishing central laboratories in Europe. Although cultural differences and language difficulties are not easy to overcome, the essential abolition of strict customs control within the European Union in January 1994 has significantly relieved transport difficulties. |
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While open borders have helped, both sponsor and central laboratories need to devote a significant amount of effort to ensure the efficient collection and delivery of samples to the laboratory. Although the courier system in Europe is not as well developed as in the United States most difficulties arise because of language differences and the lack of understanding of each other's business. Some general physicians, who are already overworked and stretched to the limit, find it difficult to cope with the additional administrative burden of arranging collection, filling out forms, and handing specimens over to the courier. Some courier staff, on the other hand, fail to appreciate the urgency with which blood samples should be collected and delivered. For the successful utilization of central laboratories in Europe the sponsor must address these issues by easing the administrative burden on the investigator and communicating effectively with the courier. The practical difficulties can be classified as taking samples, sample packing/documentation, and sample transportation/delivery. In order to avoid jeopardizing the delivery of clean samples for analysis and rendering any testing service null and void, the following must be agreed with the investigator before the start of the trial and the procedures established. |
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(a) Clinical trial center may not have a centrifuge to separate serum/plasma, so one must be provided. |
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