By Chuck Drucker , Guy Rachmuth, PhD , Jian Wang, PhD
Over the past few years, there has been growth in the use of point of care (POC) testing at investigator sites in clinical trials. For example, devices have been deployed at investigator sites to screen and enroll a patient in a single visit thus helping to reduce screen failure rates via a pre-screening step and providing for results more rapidly than local labs. In each of these cases, the POC laboratory devices were used for screening, but device data was not submitted to regulatory authorities. Instead, samples were sent in parallel to the central laboratory company (central lab), a clinical trial laboratory with globally harmonized laboratory systems and processes. The central lab produced lab reports for the clinical trial investigators and performed the data transfers to sponsors, who need the data for regulatory filings.
The article addresses why sponsors do not typically utilize data from POC laboratory devices in regulatory ﬁlings, the integration of POC laboratory device data with clinical trial laboratory systems, and whether POC laboratory devices will replace brick and mortar labs.