Resourceful Recruitment
by Leslie Whitaker
January 2008
Recruiting clinical trial participants from narrow populations requires ingenuity, creativity and patience.
Recruiting and retaining subjects for most scientific studies is a challenge, but it is particularly difficult when the roster of potential subjects is relatively small or narrowly defined. While children are among the most difficult subjects to recruit, researchers whose studies require the participation of subjects suffering from a particular disease or those who have specific demographic characteristics also must use some ingenuity.
“When you are looking at special segments of the population, you have to find them and then sell them on the study,” says Marcia Stefanick, Ph.D., chair of the Women’s Health Initiative Executive Committee and professor of medicine and obstetrics & gynecology at Stanford University, in Palo Alto, Calif., USA. “You need to understand marketing to a certain extent.” Consequently, scientists who engage in drug and other medical research typically develop outreach efforts designed for doctors and patients, design incentives for participation or engage in media relations to promote a positive image; often they do all three.
The most willing subjects are typically those who have no alternative and are convinced that the treatment being tested is their most viable option. This is also true of parents of ill children. Participating in a study is “[an] easy [decision] for parents who feel they have no recourse,” says Dr. Gail Pearson, chief of the heart development and structural diseases branch, at the U.S. National Heart, Lung and Blood Institute and scientific project officer for the Pediatric Heart Network, in Bethesda, Md., USA.
For those patients who are less certain about whether a tested treatment will benefit them (or their children), a common motivator is altruism. “To some extent it’s not about the participant but about the greater good,” Stefanick says. Many of the women who volunteered to participate in the Women’s Health Initiative (WHI), a 15-year study that focused on the health issues of post-menopausal women, for example, expressed their hope that they were helping future generations. “I’m doing it for my daughters and granddaughters,” was a common refrain researchers heard from their subjects, Stefanick says.
Large Numbers
One of the largest and longest studies of a special population, WHI had an ambitious recruitment goal: 160,000 women who were of post-menopausal age and in good health. The goal, reached in 1998, required three years of aggressive outreach. Engaging so many women in what was then conceived as a 10-year study required a multi-pronged approach. Mass mailings to thousands of women went out every week for several years. “We were lucky to be able to get the Medicare mailing list,” says Stefanick. Because so many subjects were needed, WHI contracted with 40 medical centers around the country, each with a mission of recruiting 3,600 women. Several sites took on even higher goals. One site made a goal of recruiting 4,500 subjects, and other sites agreed to recruit 5,400 subjects. Depending on their patient populations, some centers specialized in outreach to women from minority groups. Ten years out, the study was extended another five years, which meant re-recruiting for extended retention was necessary.
Mailings generated only about a 2 percent to 4 percent response rate, which was not enough. That meant employing numerous creative local community outreach techniques by each site, including maintaining good relationships with local media in hopes of attracting journalists’ interest in the study and subsequent positive coverage. For example, Stefanick and her colleagues posted flyers and spoke at senior centers, churches and women’s health groups where women ages 50 through 79 were most likely to receive the targeted message. “I tried to find out where I could go to speak to at least 20 people, even if only three might be eligible,” Stefanick says. “It was a lot of work.”
Stefanick’s other studies focused on weight loss, which were easier to recruit for. For these randomized trials, Stefanick promised all who wound up in the control group of a randomized study would receive a diet and exercise program at the end of the study. Other studies appealed to recruits by offering free cholesterol screening and other potential health benefits. “Each study has its own twists,” Stefanick says.
Media Outlet
Because the media tends to give more coverage to research disasters than discoveries, media outreach also is critical to maintaining the pool of potential subjects. Stefanick recalls working hard to entice journalists to write stories about WHI before it even started. “It’s hard to get newspapers excited about a study that hasn’t even begun,” she says, but the WHI had some success by couching it as benefiting “a special group of people [post-menopausal women] who were being ignored.”
The Internet is another promising recruiting tool. In Great Britain, research networks are being fashioned by the National Health Service, which has a potential database of all 60 million citizens.
Currently six topic-specific networks are under construction: cancer; mental health; neurogenerative diseases, including Alzheimer’s; stroke; diabetes; and medicines for children. “By having these networks, which bring together investigators in those areas, the aim is to make subject recruitment easier and faster,” says Dr. Richard Tiner, the London, U.K.-based medical director of the Association of the British Pharmaceutical Industry (ABPI). The results are promising. Currently, 12 percent of the British population with cancer are involved in a clinical trial, the highest rate of patient involvement in research in the world.
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