Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date. What statistical methods are currently being used in clinical trials to report laboratory test that come from different laboratories?
Example: A clinical trail is being conducted in multiple sites. The laboratory tests that are part of this trial are being run at different laboratories. Assuming that there may be some lab-to-lab variance in the results, what statistical adjusting is usually performed to assure the validity of these results?
Marty Markowitz, M. D.
Clinical Director
Staff Investigator, Aaron Diamond AIDS Research Center
Associate Professor, Rockefeller University
Most multi-center studies do not rely on "muti-site" labs for primary or even secondary endpoints...generally reference labs are used for most large multi-site studies....
However, in the event that local labs are used...they are generally for safety monitoring and not for outcomes (i.e. viral load or more specialized testing).
In the event that there are mulitple labs used, in general, they are CLIA/CLEP certified and must adhere to strict regulations...there are very rigorous QA/QC programs for virology and immunology labs.
More information can be found on the AACTG website
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