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How faculty recruit subjects for drug trials |
By Scott J. Turner
Researchers who need to recruit subjects with particular illnesses go to great lengths
to find the right people, even placing ads in newspapers.
(The sports section works best, they say.)
She was a smoker for 30 years. But Dorothy Henley’s overwhelming desire was to quit the habit, and she thought her best chance for success would be through a smoking-cessation study or program.
Two-and-a-half years ago, Henley saw an ad in the Providence Journal for a research study at the Miriam Hospital, where she worked as a bookkeeper. Researchers were looking at the combined effect of medication and group psychotherapy on smoking cessation. Henley called the number in the ad, made it through the screening process, participated, and has been smoke-free for two years.
“I was aware of the different research projects taking place at the hospital,” she said. “When I saw in the ad that the study was taking place here, I thought I would take advantage.”
When it come to finding human subjects for drug trials, faculty in the School of Medicine employ a range of recruitment strategies. Robert Swift, M.D., is an associate professor of psychiatry and human behavior and associate chief of staff for research and education at the Providence VA Medical Center. Swift investigates medications and psychotherapies to help people with drug and alcohol addictions.
“If the research involves people with certain illnesses, such as alcohol dependence, we will use the medical network for referrals,” he said. “We will meet with groups of doctors at the various hospitals to discuss the studies. If we decide to advertise, we will put up recruitment posters at the hospitals.
“However, if the research involves people without certain illnesses, and we need normal volunteers, we will usually use posters, placed on college campuses, in supermarkets, or elsewhere. Sometimes, we will use direct advertising, particularly newspaper ads. We’ve tried various sections of the newspaper and found the sports section produces the best results.”
One of those ads appeared recently in the Thursday and Sunday editions of the Providence Journal. The ad invited men and women struggling with alcoholism to enter a new study to examine the combined effect of state-of-the-art counseling and medication to reduce the craving for alcohol. Late last year, Swift and colleagues in the School of Medicine received $1 million to conduct the study, which is part of an 11-university 1,700-patient effort funded by the National Institute on Alcohol Abuse and Alcoholism.
Occasionally, Swift and colleagues pay some of their research subjects a small sum as compensation for their time and expenses.
“To recruit participants, you have to provide an incentive, and there are incentives for two different kinds of studies,” he said. “For those getting free treatment for an illness, there is usually enough incentive to be recruited without offering money. It might be a treatment they can’t get elsewhere. For volunteers without illnesses, we provide incentive by paying and providing transportation.
“However, sometimes we pay people with illnesses, but it depends on the treatment involved. You have to help compensate people for their trouble, in giving up time. You may be exposing them to some risk, after all, as all medications have side effects.”
Howard Safran, M.D., recruits patients primarily through referrals from primary care physicians and gastroenterologists. Along with other Brown collaborators, the assistant professor studies drug and radiation cancer treatments, most recently for pancreatic and esophageal malignancies.
Two of Safran’s current studies involve three drugs used to fight pancreatic cancer. Most pancreatic tumors are hard to detect at an early stage, said Safran, who is based at The Miriam Hospital and Rhode Island Hospital. When they are found, the tumors have often spread locally into lymph nodes and surrounding blood vessels. These malignancies may be too extensive to remove by surgery, he said.
The 18 people involved in one of Safran’s studies, being conducted at both Miriam and Rhode Island hospitals, are part of a group of 1,000 patients enrolled at sites across the nation. “Most people do want to try the treatments,” he said. “I think people hear from media about a lot of new treatments, and want what is considered state of the art. People also know that these are bad cancers.”
Reaching out to the community with word of new studies is at the core of Ken Mayer’s recruitment efforts. The physician and professor of medicine and community health, based at Memorial Hospital of Rhode Island, investigates how HIV affects people over time as well as why people engage in risky behavior. Mayer also looks at ways to improve treatments for people with HIV, including the use of biological agents to prevent HIV infection.
Mayer’s research is highly collaborative, involving such faculty colleagues as Charles Carpenter, Tim Flanigan and Susan Cu-Uvin at Miriam Hospital. Currently, Mayer and colleagues are studying vaccines to prevent the spread of HIV as well as topical anti-viral microbicides to prevent transmission of the virus.
“We do a variety of community outreach,” Mayer said. “Some of it involves ads that appear in the Providence Phoenix and public service announcements that run on radio. We are also working with community groups as well as getting doctor referrals.
“Some of the studies are designed to assess product safety and involve recruiting low-risk individuals. For these we will go to student health services, such as at Brown, to recruit.”
Henley was a participant in one of two ongoing research studies investigating the combined effect of the antidepressant Zyban and group psychotherapy on smoking cessation. The two studies, one funded by the National Heart Lung and Blood Institute, the other by the National Institute of Drug Abuse, are joint efforts by faculty and staff at Miriam Hospital and Butler Hospital.
Over the past 3 1/2 years, Elizabeth Lloyd and principal investigators Raymond Niaura and Richard Brown have recruited 460 people for the studies. The researchers have employed traditional routes to recruitment, including newspaper ads and radio spots. Because federal agencies mandate that a certain percentage of subjects come from minority populations, Lloyd and colleagues have run ads in newspapers like the Providence American, read primarily by minorities.
In addition, information about studies has been distributed to primary care offices, dental offices, emergency rooms and among community groups, and will soon be shared with church groups, said Lloyd, an assistant professor of psychiatry and human behavior, based at Miriam. The researchers also conduct health presentations on the dangers of smoking.
“In Rhode Island, it is more difficult to recruit minorities for studies,” Lloyd said. “Rhode Island has a low minority rate, about 6 percent, which is lower than many states. That means we need to make extra efforts to recruit.”
One of the more novel recruiting approaches is an ad for the Zyban/psychotherapy treatment that runs on cable TV. Lloyd said the ad, now almost a year old, has produced a “good response.”
About five months ago, the researchers also began advertising on oso.com, where potential recruits can fill out some of the required paperwork and submit the material for processing.
For individuals who respond to the Zyban ads, there is a 25-question phone screening to determine eligibility, said Pam Boffi, who supervises Lifespan’s Physician Referral Department, which conducts the phone screenings. Callers who qualify attend a one-hour informational meeting. Those who don’t make the cut will still receive smoking cessation information, she said.
After Henley attended her orientation session, she decided to continue as a participant. If people want to make a change in their lifestyle and are considering joining a study, they can always make their decision to participate after learning more about the research, she suggests.
“Once people went to an orientation, they would have to decide if it’s the program for them,” she said. “I decided to participate because I thought it was a program I could try and that hopefully I would be successful at.”