Abstract
The performance of laboratory tests in clinical trials includes many steps from sample request to report. In specifying the laboratory support for a trial, the service required by both the sponsor and investigator should be considered in conjunction with three financial components: laboratory service, transportation, and data collation. Several factors affecting the selection and assessment of laboratory performance are discussed. The cost components of the differing laboratory options are variable with the nonlaboratory costs, that is, those related to sample transport and data collation often outweigh the analytical costs. The choice between local, central, or regional laboratories should be made after consideration of these factors, and with the recognition that a single policy for choosing laboratories may not be appropriate for all studies. By analyzing and reviewing all of the procedures involved, problems relating to laboratory services can be minimized.
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