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subsequent statistical analysis. It was our belief that the efficiency and cost-effectiveness of the Zeneca laboratory would be improved by the laboratory supporting Zeneca's European clinical programs and that the company would also directly benefit by having consistent quality data, validated on an on-going basis and electronically transferred to the clinical database. There was also a clear target of saving 3 months on the historic norm for the reporting of clinical trials. This chapter describes how the laboratory coped with the demands of Phase II and Phase III clinical trials, provides some performance data, and discusses the cost benefits of integrating the clinical pathology support of toxicology and clinical trials in the one laboratory. |
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II. The Choice of Clinical Pathology Laboratories |
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Within Europe 4 types of laboratories exist that are regularly used to support clinical trials: |
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(a) A local laboratory is used by investigators for routine sample testing; it is usually located close to the investigator site and is often a hospital laboratory. For more specialized tests, these laboratories may send their samples to a larger specialized laboratory. |
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(b) A regional or national laboratory is used by all investigators in a multicenter trial conducted in a certain region or country. These are, invariably, contract laboratories that organize an efficient national sample transport system and result-reporting procedure. |
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(c) A network of laboratories consisting of several regional laboratories may be used in multinational trials. There would usually be one laboratory per country that would perform the majority of requested routine tests. These laboratories may choose to perform the more specialized or esoteric tests at a single central laboratory. In order to gain maximum benefit from such a network of laboratories it is essential that each laboratory operates to the same standard and procedures and makes every effort to coordinate their quality control procedures, instrumentation, methodologies, reagents, reporting procedures, and database formats. |
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(d) A central laboratory is used by all investigators in a trial covering a very large region, a whole continent, or the whole world. These laboratories are faced with the challenge of providing single correlated testing methodologies and standardized technical databases but, unlike the networked laboratories, these have to be managed on a global basis. Large Contract Research Organizations (CROs)such as SciCor and Smith Kline Beecham Clinical Laboratorieshave established, in the past few years, laboratories in North America and Europe, and there appears to be an intention to provide similar facilities in South Africa, Australia, and Japan. These |
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