White Paper

The Case For The Use Of Point-Of-Care Testing In Pharmaceutical Clinical Trials

Source: Blinded Diagnostics

Clinical trials that are designed to evaluate the efficacy of novel pharmaceuticals require a variety of diagnostic tests to be performed on all enrolled patients. Some of these tests, such as electrolytes, are readily available at each clinical center and are sufficiently standardized across laboratories so that each site can report their local results on the patients' case report forms and these values will be comparable. When such a test result is needed, and there is no need to blind the investigators to the result, the cost of running such tests becomes a minor part of the total clinical budget. In those cases where a test is not standardized, or is not available at a local facility, or an informed clinician could infer whether a patient is in a placebo or treatment arm based on time to result, both the cost and complexity of a trial can rise quickly.

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