Recruitment specialists can increase enrollment
Specialist takes time to build MD relationships
Study recruitment is an increasingly difficult role that requires relationship-building work among community providers and other skills that clinical trial coordinators might lack.
"Most doctors call our office because they have problems with recruitment, which is the number one problem nationwide," says Tammy Anderson, CCRC, CCRA, CRCP, director of the clinical trials office at the office of the vice president for health sciences, Virginia Commonwealth University in Richmond, VA.
"What I have found is that the personality and experience that makes a good RN and study coordinator does not necessarily make a good recruiter," she adds.
Study recruitment has changed for many principal investigators in recent years. While they once might have received dozens of phone calls from a radio or newspaper advertisement, now they find the phones are quiet and finding potential subjects to screen is a challenge. But sponsors still allocate only a limited amount of resources to recruitment, so many studies flounder with no or too small enrollment, Anderson says.
One solution is to hire a contract study recruiter through a research institution's centralized research office, she suggests.
"Our university is supportive of our clinical trials office, and we were given funds to get started so we could provide the role of a recruitment coordinator," Anderson notes. "But it's interesting to me that the key factor sponsors need is recruitment, yet none of the sponsors will pay for a recruiter or marketer; they'll pay for advertising, but they won't pay for a site to have someone dedicated to recruitment."
The problem likely is that sponsors still operate under an older system that expects investigators to recruit easily through traditional advertising methods, despite evidence that the old way is not working well in the 21st century, she explains.
"In 2000, sponsors were spending $400 million a year in recruitment advertising; in 2008, that figure was up to $515 million," Anderson says. "Yet inquiry rates have dropped to less than 1% from 3%, and randomization rates declined from 75% of screens to less than 60%, and completion rates are running two-thirds to less than one-half."
A best practice way to handle recruitment is to build relationships with clinical practices and have staff that can focus just on recruitment, Anderson says.
"We need to find a way to get sponsors on board with supporting the physical recruitment efforts and not just the advertising costs," she adds.
Some research institutions are facing the reality of study recruitment challenges and are devoting their own resources to hiring recruitment specialists.
The Virginia Commonwealth University's new centralized CT office offers researchers a wide range of services, including contract staffing for the purposes of study recruitment. This role has proved invaluable to some investigators.
For example, one long-time investigator who typically had 20 to 30 ongoing studies per year had been cutting back because her research coordinators could not keep up with enrollment work, Anderson explains.
"She originally had two or three coordinators who would do all of the IRB submission work, handle advertisements and call scripts, do all visits, complete case report forms (CRFs), coordinate monitoring visits, handle regulatory information and continuing reviews," she says.
What would happen is they'd begin to enroll for a new study and then get so bogged down with the other duties they wouldn't have time for aggressive recruitment practices when enrollment slowed down, she adds.
So this particular physician investigator was having problems with recruitment and called the clinical trials office for help.
Anderson assigned a recruitment coordinator to work with the physician, and this person handled telephone calls and met with physicians at local primary care offices and specialty clinics to identify patients who might meet the study's criteria.
The recruitment coordinator had built trust with community providers and their staffs. So when patients came in who might meet the study's criteria, the staff would ask if they'd like to speak with a research recruiter, who happened to be sitting there.
Then the recruitment coordinator would make appointments for patients to come into a satellite research clinic to be screened for a study.
"Our recruitment coordinators spend all of their time recruiting for all of the studies we have that are open for recruitment," Anderson says. "They might recruit for several different physician investigators, and they suggest to clinic nurses that a particular patient might be a candidate for a study so they would give the patient a brochure."
Since the recruitment coordinators carry around Blackberry phones, they are able to respond quickly to any recruitment calls or emails they receive, she adds.
"They've already done the legwork to have relationships with physicians," Anderson explains. "But it's important to have someone be physically there in the doctor's office, serving as a constant reminder to the clinic team."
These specialized recruitment services had an immediate impact on the investigator's study enrollment: within six weeks, the recruitment coordinator had enrolled 12 study participants in trials that had been unable to enroll even one person over a number of months, she says.
The investigator had been at risk of losing three projects because she couldn't enroll patients in these studies. The recruitment coordinator had identified three to four patients in each of those studies, meeting two 30-day deadlines.
"The phones are ringing off the hook, and the recruitment coordinator has a list of patients responding to ads," Anderson adds. "We're identifying patients daily who are interested in participating in clinical trials."