White Paper
ICON Insight: Imaging And Cardiology
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•White Paper: ICON Insight: Imaging And Cardiology
By Jonathan Goldman, M.D., FACC, Chief Medical Officer, ICON Medical Imaging
Imaging has an increasing role in the evaluation of cardiac safety where it is used together with adverse events, ECG, and laboratory tests for cardiac enzymes to assess for cardiac toxicity. This is most often found where animal studies suggest possible signal for safety concern, or where cardiac toxicity is a known class effect for toxicity.
Imaging studies in some clinical trials are performed and interpreted at clinical sites according to standard of care. This is not ideal in the clinical trial setting, since it introduces bias in the way that images may be acquired or interpreted, without the use of a single methodology or ability to query potentially erroneous findings (or beneficial ones). In the worst case, false documentation of a safety concern could mean withholding of chemotherapy. Conversely, missed cardiac toxicity could lead to early mortality induced by an experimental drug. The role of a central lab is to provide medical, technical, statistical, operational and regulatory expertise to the imaging study. Good standardization and training should avoid such false signals and ensure high quality data.
It is clearly essential that sites have adequate equipment to acquire and archive images, and have adequately qualified staff, who are prepared to be trained on the particular protocol. This can be problematic, as in some studies the Imaging laboratory has only limited relation to the investigator. Good communication between the clinical CRO, core laboratory, imaging laboratory and study coordinator is key.
Click Here To Download:•White Paper: ICON Insight: Imaging And Cardiology
