Impact of biomedical imaging and data visualization technology on the clinical development and regulatory review process

• Main Authors: Conklin, James J, Robbins, William L
• Format: Conference Proceeding
• Language: English
• ISSN: 0277-786X
• DOI: 10.1117/12.195458

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 reviewed. 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.