By Deborah Borfitz

Sept. 3, 2008 | In the U.S., the chief challenge of recruiting patients into clinical trials is not disinterest but “putting information in front of people so they can make a choice,” says Rick Malcolm, CEO of Acurian. It is a task that the Horsham, PA-based patient recruitment firm has clearly mastered after more than a decade in the business.

Over the last three years, Acurian’s opt-in database of self-reported chronic disease sufferers has grown from eight million to more than 50 million patients, and half a million of them have been screened for trial participation, says Malcolm.

The majority of patients were added to the database via exclusive partnerships with a handful of large health data aggregators, says Malcolm. The patients include both survey respondents who opted broadly to receive health information about their medical condition and those who opted specifically for information about clinical trials. The rest of the database is populated with visitors who have registered their interest in trials at the Acurian website. Virtually all patients reside in the U.S.

Data provided by aggregators is not always accurate, so Acurian “carefully screens” companies and tests the information in a controlled environment before committing to a partnership, says Malcolm. But some inaccuracies are unavoidable because the data is self-reported.

Letters approved by a variety of institutional review boards get mailed to people in the database appropriate for particular clinical trials based on their self-reported medical condition as well as demographic characteristics such as age, gender, and address. An internal survey conducted earlier this year found that people who respond to the invitations represent a span in ages, says Malcolm. Respondents are twice as likely to be females as males, but a full 80 percent have health insurance.

The cost to sponsors runs about $4,000 to $5,000 per patient, says Malcolm. Dollar for dollar, the effectiveness of the database approach beats the alternatives of radio, television, and newspaper recruitment campaigns where messages can be targeted, at best, by gender and age. The attractive price reflects both the size of the database and efforts to “increase the efficiency of every step in the process,” including sites’ aggressiveness in pursuing referrals.

Though “not as sexy as a TV commercial,” Acurian is willing to sign patient recruitment contracts predicated on the company’s ability to meet specific recruitment milestones, including randomization. The database approach is predictable enough for Acurian to take the business risk and “allay customers’ fears that they’ll spend a lot of money and get very little results,” says Malcolm. Greater selectivity and better results would be possible only via electronic medical records, which are “not yet that prevalent” and might well stoke privacy concerns.

Depending on the therapeutic area, says Malcolm, Acurian’s direct mail campaign typically gets a response rate of .05 to 5 percent. After giving those patients an overview of the trial, about 80 percent choose to be pre-screened. Due largely to protocol exclusions, no more than half of that population will pass the pre-screening and be contacted by an investigative site.

Of those who pass the pre-screening, 25 to 40 percent will show up for the first visit to meet with the investigator to learn if they qualify, says Malcolm. “For mental health conditions, there’s a high degree of no-shows by virtue of the condition itself. But once they come in . . . around 85 percent will sign informed consent documents.”

Acurian’s “biggest challenge” has been in attracting patients with terminal or life-threatening conditions, says Malcolm. They’re still more apt to seek solutions, on their own, through one of the online trial listing services.

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