How to save time in a Clinical Trial...
Updated: Apr 29, 2019
For a clinical trial, the application of POCT is typically driven by the need for speed.
Speed that can be of benefit to both the Study Subject and the Sponsor.
Increasing the rate of enrollment can potentially shorten the total Study time and reduce screen failure rate.
Having access to results on the same day (of the Study Subject visit) can have an additional benefit as a dose adjustment tool that saves on enrolled Patient's travel time.
Monitoring tests for safety during the course of treatment can also be accomplished with POCT on the same day of a visit.
Clinical Operations Executives ask “What tests are available on Point of Care devices?”
The answer is over a hundred, however, these tests come in a variety of platforms, specifications and are sold by dozens of manufacturers and vendors. To simplify the search for the right test, the website www.pointofcare.com was built to help find POCT options based on the name of the test(s) that you are searching for.
This site uses a database filled with specifications on each POCT test platform and allows a view of comparative platforms.
What specifications are important in POCT for use in a clinical trial?
Accuracy compared to Central Lab Instruments: The package insert of the POCT device has data for comparison with a lab instrument standard using a “r” value or CV. This is required information for manufacturers to have prior to gaining commercial approval.
Reportable Range: Also found in the P.I., this is essential for comparison with the study protocol.
Test menu: POCT has single and multiple test platform menus. Tests like Glucose, HbA1c and Hemoglobin can be found in both formats. While CBC, Lipids and Chemistry (blood and urine) are often just multiple test platforms.
Reagent Stability and storage: Room temperature reagents with 12 month stability are not uncommon. Before going ahead with a POCT plan, it’s a good idea to ask for recent lot stability data from the manufacturer of the test. In some cases, its also possible to request a sequestered lot for your study to make it easier to manage stability and standardization at investigator sites.
Sample Size: A fingerstick whole blood sample is ideal for POCT, which means 2-3 drops of blood (<30 microliters). Most single test platform devices use a 1.5 microliter sample. Compare devices on sample size.
Power requirements: POCT devices that are powered by off the shelf commercial batteries offer the most flexibility. Rechargeable models are readily available. The larger table top multiple test menu devices require a power source but may have battery backup to save data.
Country availability: For a Global clinical trial, make sure the source of the device has the ability to get the device into the countries where your sites are located.
To read more about Studies that have successfully utilised Point of Care Testing devices visit our Projects page at https://www.blindeddiagnostics.com/projects