With the development of fluorescence spectroscopy, multicenter clinical trials are becoming more common both in the
academic and commercial arenas. To ensure the quality of quantitative and device independent results, standardization
of the tissue spectra is essential for the comparison of data from various groups. An added concern is the potential
degradation of instrumentation during a trial which may affect the instrument's ability to accurately represent the tissue
spectra. Our group has recently completed a Phase II clinical trial for the detection of cervical neoplasia using two
different generations of spectroscopic devices at multiple sites. Both positive and negative optical standards were used
to calibrate the tissue spectra as well as aid in the diagnosis of potential instrumentation problems during the trial. We
have also conducted a cross validation study of fiber optic probes, spectroscopic devices, and optical standards for the
latest generation of devices. The spectroscopic data of optical standards were analyzed for both the clinical trial and
cross validation studies. Results demonstrated perceptible differences in optical standards data between the two
generations of spectroscopy devices in the clinical trial, as well as the cross validation study with multiple devices of the
same generation. Although the spectra were unexpectedly different, tissue spectra measured with the different systems
can be empirically corrected by use of the various optical standards. Device performance during the clinical trial also
was a concern; however, with the use of optical calibration standards, instrumentation problems were easily identified.
To eliminate the problems associated with instrumentation, we have recently developed real-time quality assurance
software to assess the optical calibration standards immediately after acquisition.