Happens every day. Study participants fail to show up at the clinical site for blood draws. Or they go on vacation for two months, making it impossible to track them. Or maybe they’re too sick to get to the site.

Sponsors who are weary of such complications might want to get in touch with Chicago-based Clinical Resource Network, which will visit with study subjects in their home, or their work place, or wherever they’re on vacation. At that location, they draw blood, administer a drug—whatever your protocol calls for. The study isn’t delayed, and your data doesn’t skip a beat.

But how? The firm subcontracts with (so far) 2,000 accredited home health agencies in the U.S. and Canada, training registered nurses to work with study subjects and sending them into the field. 

Going There

“We take the clinical trial to the patient instead of the patient having to come to the investigational site,” said company founder and president Gail Adinamis, adding that the average drop out rate for a trial conducted the traditional way is about 25 percent, but when one visit subjects where they are, that number drops to about 5 percent.

Sponsors are taking note. Clinical Resource, which entered the market in 2003, worked on about 100 trials in the three years that ensued. In 2007 alone, though, the company is slated to do 50 trials, said Adinamis. In the spring, Clinical Resource began a pilot program in the UK, where it plans to expand next.

Venture-Backed

This month, the company got venture capital backing—Adinamis wouldn’t say how much—from WHI Capital Partners of Chicago. With the cash infusion, Adinamis says she wants to grow the company 10-fold. She recently added to Clinical Resource’s dozen employees, bringing on three new executives. And she’s currently searching for a vice president of business development, which will, she says, round out the executive team.

Adinamis explained that sponsors who contract with Clinical Resource offer in-home or at-work visits to subjects, while also giving them the option of going to the clinical site, if that’s what they prefer. About 80 percent of the time, they opt for visits from home care nurses, she said.

Word of Mouth

Clinical Resource, says Adinamis, has worked with a mixture of big and small pharma as well as biotech clients. Most seem pleased, as about half of the company’s new clients come via word of mouth, she said. 

Thus far, much of Clinical Resource’s work has been in the therapeutic area of oncology, but the service can be applied across all studies, Adinamis said. It’s especially useful for pharmacokinetic studies, where a subject’s blood may have to be drawn several times over the course of a few days, which often includes weekends. “Home care nurses can make it much easier for patients to participate in a study like that,” said Adinamis.

No Flight Necessary

The service is also very useful for studies looking at rare diseases, she explained. In those cases, subjects might live hundreds of miles from the nearest clinical site and would otherwise need to be flown in. Having a nearby home care nurse drop in instead is tremendously valuable to a sponsor, she said.

And nothing in the protocol usually needs to change. Informed consent is the same, except for an added clause that says the study drug may be administered through a study site or a home care professional. Often, subjects must come to the site for their base-line visit and end-of-study visit, with all visits in between done by home care nurses.

Clinical Resource isn’t quite alone in the market, but close. It’s the only firm that focuses entirely on taking trials to subjects in their homes, though in the 1990s Adinamis did help two other companies set up small subsidiaries to do much the same thing.

Helping other companies dip their toe in this market made her see that this was the way to go. “I realized this was an innovative model,” she said. “I knew it was the direction I needed to go in.”

—by Suz Redfearn