Laboratory Testing at a Distance

Abstract

Pharmaceutical companies involved in multicenter clinical trials presently face the choice of whether to use the laboratory facilities of the participating study centers or a centralized laboratory. This subject has been a matter of debate for some time and is partly confused by the fact that different aspects of laboratory testing are considered with the same arguments. There are fundamental differences, however, between testing for patient safety monitoring and advanced testing for effects or side effects of drugs. To distinguish these centralized set-ups, the terms central and core laboratories can be applied. Central laboratories are those involved in safety monitoring, which requires overnight transport of samples, immediate assay, and on-line data transfer, whereas advanced testing is the area of core laboratories. Besides the actual testing, core laboratories should provide expert advice on the assays to be performed as well as their interpretation, and should be able to perform experimentation to support the sponsoring company in its field of expertise. A centralized set-up, of course, may be able to provide both services. Various aspects of central and core laboratories will be discussed.