Headhunter finds experts to read drug trial images

March 8, 2007

Ever since the FDA accepted the use of medical imaging to indicate the efficacy of experimental drugs, the need has been growing for qualified radiologists to interpret images from clinical trials.

Ever since the FDA accepted the use of medical imaging to indicate the efficacy of experimental drugs, the need has been growing for qualified radiologists to interpret images from clinical trials.

A new company, Radiology in Medical Development (RadMD), is meeting that need by finding expert radiologists who can perform an independent evaluation of images from clinical studies.

Formed in September 2006, RadMD has created and continues to build a database of interested and eligible clinical readers who are expert at interpreting images from all types of modalities. Through word of mouth and its website, RadMD has amassed a cache of such radiologists in the U.S., U.K., continental Europe, and India. It will soon add radiologists in South America.

The firm serves as a subcontractor for drug companies or contract research organizations (CROs) that are leading clinical trials and may need to arrange for the services of two to four blinded readers per trial, said Dr. Rick Patt, a radiologist and consultant for pharmaceutical and medical device companies. He founded RadMD with Dr. Kohkan Shamsi.

When a drug company or CRO comes to RadMD, it explains the nature and scope of an upcoming clinical trial and identifies the number of blinded readers needed. RadMD then combs its database to find and present to the company a list of suitable candidates. After the drug company makes its selections, RadMD hires the radiologists to participate in the trial.

By acting as a clearinghouse, RadMD is helping pharmaceutical companies assure that radiologists are truly blinded readers, Patt said.

"It's important when radiologists come in to evaluate images that they are independent of the drug company. So the drug company should not be the one going out and hiring the radiologists," he said. "By using us as a subcontractor, a drug company separates itself a step further and reduces the risk of bias."

Since the Modernization Act was passed in 1997, the FDA has been allowed to speed the drug approval process by reviewing the effect of a new drug on surrogate end points that predict clinical benefit rather than on traditional survival data. As a result, 53 of 71 oncology drugs were approved for marketing between 1990 and 2002 on the basis of such surrogate markers as a change in tumor size measured by MRI or CT. The number of blind reads, therefore, has more than quadrupled in the last five years in the U.S. alone, Patt said.

Despite this demand, RadMD has virtually no competitors, at least none that can deliver as many readers as RadMD can.

"Some companies have maybe five to 15 radiologists who can do blinded reads," Patt said. "Our advantage for drug companies is that we have hundreds of people to choose from, so they can get the best person for their clinical trials. When you are spending millions of dollars to do imaging in a clinical trial, you want the most qualified person with expertise in that area. We think we have a real advantage there."