ACR launches research outsourcing firm

The American College of Radiology has announced the opening of its own contract research organization. The ACR Image Metrix will offer imaging research services to companies that seek FDA approval for drugs and medical devices but prefer to outsource their research operations to cut costs.

Traditional contract research organizations help design and develop research protocols, provide quality assurance, collect data, and interact with regulatory agencies to speed up a drug's market approval process. They perform these steps competently but often lack a sophisticated imaging component that tells whether the drug is working. That would be the company's job, said Dr. Bruce J. Hillman, ACR Image Metrix director of scientific affairs.

"We would organize the imaging protocol, set the quality standards, and make sure of all the regulatory approvals where necessary. We would handle the finances and logistics, collect all of the imaging data that need to be submitted to the FDA, and even assist the company in working with the FDA," Hillman said.

ACR Image Metrix was born as an offshoot of the American College of Radiology Imaging Network. Through almost a decade, ACRIN has built a robust infrastructure to perform imaging clinical trials. The timing was simply right to put that infrastructure at the service of the pharmaceutical, biotechnology, and medical device industries, Hillman said.

Companies developing new drugs and devices face not only hefty costs but also dodgy regulatory hoops to get a new agent or a device into the marketplace. ACRIN's experience in design, analysis, and dealings with regulatory agencies might help move innovations more quickly into clinical care. Catching on with industry, though, could be tricky.

"The main challenge will be to move from an organization that has worked on federal funding to making it known to the pharmacy and device industries that we are in this business. Also, getting the chance to show the excellent work that we've been able to do in the not-for-profit side on the for-profit side," he said.

Once that occurs, though, it should be a win-win situation, Hillman said. Industry contracting with the organization will pocket the money it's supposed to at the end of the process. The for-profit ACR Image Metrix will funnel earnings - if there are any - back into ACRIN to fund more not-for-profit research.

There will be no stockholders and no money for lobbying. All money should go back to ACR research, he said.

"When industry contracts with ACR Image Metrix, they are helped in two ways: They're helped specifically by the products we are running clinical trials on, but they are also helped because new clinical trials get done more generically as well. That helps to advance and get reimbursement for new technology," Hillman said.

ACR Image Metrix will be headquartered at the ACR's Philadelphia office, which also hosts the clinical research division. This branch has provided administrative, data management, information technology, image archiving, and statistical support for more than 500 clinical research studies over three decades.

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