On Target
by Heidi Moore
January 2007
In the United States, focused recruitment strategies lead to better retention and improved trial results.
In every U.S. clinical trial, hundreds of decisions are made before the first patient signs a consent form. But getting that patient enrolled—and, more importantly, getting that person to stay through to the end—is critical to a trial’s success. Recruitment problems, low retention rates and lack of patient cooperation can cause serious delays in a trial and even compromise the results. There are no quick solutions to guarantee high patient enrollment and retention rates, but a few carefully considered strategies throughout the life of the study can increase the likelihood of success.
Start by planning ahead—way ahead, before the first patient sets foot in the door, says Frank S. Kilpatrick, president of Healthcare Communications Group, an El Segundo, Calif., USA–based marketing communications consultancy that assists pharmaceutical companies and other clients with clinical trial recruitment and retention.
Site Unseen
The first step for a trial’s sponsor, Kilpatrick says, is to thoroughly assess the proposed sites or, in other words, the principal investigator’s research centers. Factor in everything from prevalence of the qualifying condition to the accepted medical standards of care for the condition. By evaluating these factors, trial sponsors can focus on sites that are a better match for their requirements. “[Site selection] is a critical process that shouldn’t be undervalued,” Kilpatrick says. “We’re all better off when we can preempt the problems by finding the right sites, rather than trying to fix the [evaluation] process after the fact.”
Once the sites are determined, the call for patients must reach a wide pool of potential participants. In the United States, newer recruitment tools, such as dedicated Web sites and e–mail announcements, have joined traditional methods such as print, radio and newspaper ads. Often, a combination of these tactics ensures a greater response. “What works best is an art, not a science,” Kilpatrick says. “Mass media tools work for discretionary trials [that involve] lifestyle situations, such as sexual health and fibromyalgia, to reach large masses on a preventive level,” Kilpatrick says. For clinically focused trials, on the other hand, “only a doctor can tell you if you have the right lab values,” he says.
Target Practice
For the clinically focused sector, professional education works best, Kilpatrick says. Presentations to physician groups, advertising in professional journals, health fairs with on–site pre–screening, and direct communication with healthcare networks and hospitals all can be successful in educating physicians about ongoing trials. Site coordinators must be educated about the trial’s specific protocol, Kilpatrick says, or they won’t be well received by a medical team juggling many high–priority demands.
This on–the–street approach can be personnel intensive, but Kilpatrick says it pays off in the long run. His team has gone everywhere, from Alcoholics Anonymous meetings and free clinics to gay clubs and cruises, to recruit patients for different clinical trials. “You have to go into the community with credibility to be successful at this,” he says. “You can’t do this sitting at your desk. If you want to find out what the real issues are, you have to have people out there to make a difference.”
In addition to seeking out patient groups, target the medical professionals to help you as well. “One of the best [recruitment methods] is for a patient’s physician to let them know there’s an opportunity for a study,” says Brenda Reith, an information systems educator in the Educational Services Department of CoxHealth Systems, Springfield, Mo., USA, and a former study coordinator for Cox. Her team has established relationships with a number of doctors who alert their patients to upcoming trials. There’s no substitute for word of mouth, Reith says. Referrals from physicians and even former patients have a high rate of success in enrolling patients.
As an additional tactic, Cox posts study information on an electronic sign facing an adjacent highway. Every week, Reith says, usually at least one person calls to inquire about the trial after seeing the sign. “And even if they don’t qualify, they tell someone else and they call,” she adds. The organization’s Web site also lists ongoing research opportunities. The key, she says, is “making the tools you have work for you.” Working with an Institutional Review Board will ensure that your recruiting methods are acceptable or even legal in your country.
Separate Wheat from Chaff
Once you have your targeted pool, make sure your screening process is geared to increase retention rates. “Any time you start talking to a patient, you’re starting that [screening] process,” Reith says. “Make sure you document well. And right off the bat, let them know [trial participation] is an option—as long as they feel that they have control over whether they do it or not, it opens them up to listening if it will be good for them.”
Finally, don’t downplay the importance of communicating and personally interacting with patients—and making sure patients feel comfortable staying involved with the trial. “Take your time to give them what they need,” suggests Amanda Dressel, a leukemia clinical research nurse at the University of Michigan Comprehensive Cancer Center, Ann Arbor, Mich., USA. “When people are frightened, knowing what to expect makes a big difference—even knowing how the study differs from standard treatment.”
When Dressel approaches potential patients about participating in a clinical trial, she makes sure to explain all the options slowly and carefully so as not to overwhelm them. “We explain things very clearly—not speaking over their head and using terms they don’t understand,” Dressel says. “People are attracted to a certain bedside manner, and a genuine caring for them and their well–being.”
Making a patient feel comfortable about participating in a trial is critical when the patient is still in the acute phase of a newly diagnosed condition such as cancer. “This is a scary time,” Dressel says. “You need to alleviate their anxiety. Gaining patient trust, taking time to make them feel like they’re important, is central. If patients trust the investigator, if they believe the investigator has their best interest at heart, they will be more likely to participate in a clinical trial that their physician recommends.” They also will be more likely to remain in the study, she says.
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