The determination of whether a drug or medical device is safe and effective requires statistical proof of valid clinical trial information. Quantitative biostatistical measures from anatomic and functional medical images are now providing objective and reproducible measures of drug and device effects. These highly precise biostatistical measures can be used to quantitatively analyze the efficacy and occasionally the safety of these drugs and devices. Since medical imaging information is digital, or is readily digitized, it can be visualized and measured in a variety of ways to evaluate the validity of the data. Moreover, with advanced image processing and data visualization tools, this information can be electronically organized and submitted directly to the U.S. Food and Drug Administration (FDA) reviewer. Biomedical imaging and computer-based data visualization technologies have the ability to substantially decrease the time required for clinical development and regulatory review while providing more valid data.

Date Published: 6 December 1994
PDF: 11 pages
Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); doi: 10.1117/12.195458

Published in SPIE Proceedings Vol. 2307:
Health Care Technology Policy I: The Role of Technology in the Cost of Health Care
Warren S. Grundfest M.D., Editor(s)