Quantitative measurements of medical images for pharmaceutical clinical trials: Comparison between on-site and off-site assessments

OBJECTIVE, In pharmaceutical clinical trials, quantitative measurements on medical images are often conducted to confirm drug efficacy. This study aim s to compare the quantitative image analysis performance of an off-site cor e laboratory with the performance of investigators from multiple clinical s ites. MATERIALS AND METHODS, In a phase I clinical trial, 25 healthy subjects und erwent dynamic brain single-photon emission computed tomography (SPECT) sci ntigraphy with I-123-Altropane, a cocaine analogue with high affinity and s electivity for dopamine transporter sites in the striatum, In 20 patients e xamined on-site and off-site, a total of 80 measurements were made to calcu late the drug's binding potential. A trained technologist off-site at a cen tral core laboratory and on-site investigators at different clinical sites performed the image analysis. These results were compared with measurements made by a subspecialty radiologist whose assessments were the reference st andard. Statistical analysis was performed using multiple regression analys is. RESULTS. Measurements from the central core laboratory (off-site) highly co rrelated (r = 0.95) with measurements of the reference standard. Measuremen ts from the clinical sites (on-site) grouped together had lower correlation (r = 0.84) with the reference standard. This difference was statistically significant (p < 0.05), CONCLUSION. Training and experience in the specific type of image analysis are critical in obtaining consistent data. Quantitative analysis by dedicat ed personnel at a core laboratory provides highly reproducible results. The findings support off-site assessment of medical images in pharmaceutical c linical trials.