Unnecessary procedures and amendments to clinical trial protocols cost sponsors more than $5 billion per year and are responsible for 20% of clinical trial budgets, according to recent research. To help reduce these costs and create zero-delay clinical trials, AG Mednet has licensed from Columbia University advanced image analysis technology developed by Drs. Lawrence Schwartz, Binsheng Zhao and Yongqiang Tan at Columbia University Medical Center.
The software, developed by the Computational Image Analysis Laboratory in the radiology department, aims to verify certain clinical study data prior to submission, a process that could reduce unnecessary procedures, protocol amendments and cost overruns for pharmaceutical clinical trials.
This technology is expected to deliver new quality control modules that check for anatomical completeness of chest, abdomen, pelvis, as well as presence/absence of contrast in CT scans at investigative sites prior to data submission, thus determining whether image sets are protocol compliant before they reach the core lab or sponsor for analysis.
“Compliance with image acquisition requirements is fundamental for proper evaluation in clinical trials,” said Dr. Lawrence Schwartz, professor and chairman of the Department of Radiology, Columbia University Medical Center, who has extensive experience in oncology clinical trials using both conventional and novel imaging modalities. “Our algorithms, together with AG Mednet’s advanced, site-side quality management infrastructure, could help confirm whether the data meets the anatomical completeness requirement and contrast usage at the investigator site prior to data submission. This may significantly cut down on data queries, enhance imaging data quality and enable investigators and adjudicators to reach clear conclusions faster.”
Abraham Gutman, president and CEO, AG Mednet, said, “Dr. Schwartz and his colleagues have created a unique set of algorithms, which adds to AG Mednet’s infrastructure, and we expect that it will provide investigative sites immediate feedback about the quality and compliance of their image sets within clinical trial protocols,”
Boston-based AG Mednet automates, expedites and improves outcomes in clinical trials by ensuring quality and compliance within critical medical imaging processes. Founded in 2005, it is a quality compliance partner for image data submission and collection for pharmaceutical, biotechnology and medical device companies, imaging core labs and CROs managing global clinical trials.