Recruiting and retaining diverse CR subjects requires focused strategies
Building trust in community is crucial
Often clinical trial sites might have adequate success when recruiting minority patients to a study, but then they are faced with high attrition among those same patients.
This suggests that when recruiting minority or diverse populations to participate in clinical research, investigators and clinical trial sites should follow a focused and strategic plan that will ensure success both in enrollment and retention, an expert says.
"If we take a more holistic approach to the whole clinical trials industry, we can start a cycle that helps us maintain numbers of certain groups in our trials," says Daniel Bustillos, JD, PhD, an assistant professor of health care ethics at St. Louis University in St. Louis, MO.
One project that has taken on this issue is the Eliminating Disparities In Clinical Trials (EDICT) research project. It was started in 2005 as a four-year program by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and the Intercultural Cancer Council in Houston, TX, funded by Genentech Inc. of South San Francisco, CA.1
EDICT has identified the three 'Rs' of clinical trials, which are recruitment, retention, and return on investment, Bustillos says.
A fourth 'R' was added after EDICT began, and that stands for resources.
Keeping the 3Rs in mind, here are some of Bustillos' strategies for improving diversity in clinical research studies:
• Recruitment of diverse populations. "There is a plethora of information out there about what kinds of interventions work as far as recruiting people and which ones don't," Bustillos says. "A lot that work are short-term and have a high drop-out rate."
While this doesn't mean the recruitment strategies are fundamentally flawed, it does mean that they're not coupled with a continued commitment by clinical trial coordinators and researchers and others to do everything necessary to keep people in a trial," he adds.
In some ways recruitment and a community's or individual's return on investment cannot be fully separated because the two work hand-in-hand, Bustillos suggests.
"Outreach shouldn't be an issue because we'll be approaching the community from the very beginning and asserting our commitment to the community," he says.
For example, academic research institutions often are located within urban areas in which the neighborhoods are diverse, Bustillos notes.
"But we often find that people are recruited not from the vicinity or the surrounding neighborhoods, but from the suburbs," he says. "What we've found is that our clinical trials primarily are composed of more affluent middle class whites."
It's a good strategy for researchers to get into their neighboring communities and build trust and interest in clinical trials through a long-term commitment to these neighborhoods, he says.
Physician investigators and other clinicians could offer free health screenings and make a true commitment to the health of these communities, Bustillos says.
"There are a million ways we could prove that commitment by going to a health fair, offering free breast cancer screening, help with the inner city asthma problem," he says.
Researchers and a research institution could make certain that they have a presence at every health fair, parade, and neighborhood celebration, Bustillos says.
"Why shouldn't an inner city research institution have a booth out there and have healthy food," he says. "They could talk about diabetes and give recipes for special diets and that sort of thing."
These kinds of efforts demonstrate that the research institution cares about the community and its problems, he adds.
And it's important that the people who work at the health fair booths or provide outreach into the community are ethnically diverse.
"Those sorts of community ties would go a long way to helping us with that initial problem of how to recruit," Bustillos says.
• Retention of diverse populations. "There are myriad reasons why people drop out of clinical trials," Bustillos says. "One is that continued involvement is often much more burdensome than patients first envisioned or that they're first led to believe."
From a trial site perspective, it's crucial to address retention issues because it's a waste of time and money when people drop out, he adds.
"Benefits do accrue to people who are on the trial even though we don't want to coerce people to stay for those benefits," Bustillos notes. "Also, when participants have a good experience on a clinical trial they're much more likely to spread the gospel of clinical trials in their communities and to their loved ones and friends, and they're more likely to participate in another clinical trial."
This, in turn, creates good public relations for the research institution within the targeted community.
The barriers to retention include daunting paperwork, transportation, and child care.
"One thing that comes up over and over in the literature as a barrier is the tangential and incidental costs to participants in a clinical trial," Bustillos says. "These are never fully addressed in a clinical trial protocol."
For example, a major barrier for some populations can be taking the time off of work to participate in the trial, Bustillos says.
"Let's say our population is maybe an inner city minority population, one of the things we'd like to see is for there to be some kind of awareness by research designers that it's a burden for this population to come and be part of the trial," he says.
"For a stay-at-home soccer mom, the burden to come in for a study is a low burden," he adds. "But for the inner city mom who is working two jobs and has no transportation, the burden to come into a research center is much higher."
Clinical trial sites can help ease this burden by providing transportation vouchers, child care during trial participation, and even meal vouchers for participants who might not have the time or money to buy lunch or dinner after participating in a trial.
"Maybe a research center has an on-site child care facility for its employees," Bustillos suggests. "They could make it available on a two-to-three hour basis for someone who needs to come in and do their clinical trial visit."
Another burden for trial participants involves the paperwork and navigation of a large research institution.
"Medical centers are daunting places to navigate from the paperwork to parking, and to some people they might seem like fortresses," Bustillos says.
"So a really good clinical trial coordinator should be good at helping people navigate the clinical trial enterprise," he adds. "And they also should be taught to be culturally competent and linguistically competent for certain populations."
One good suggestion would be for CR sites to have a designated participant navigator who is bilingual and trained in cultural competence, Bustillos says.
"The participant navigator can offer linguistically appropriate help to the population, and this is an expense we'd have to absorb somehow," he says.
• Return to the community. Interviews with members of diverse communities have shown that they often have really low opinions of researchers, Bustillos notes.
"From the community member's perspective, researchers often swoop in and tell people what the researcher needs and wants and places a high burden on them to get into a clinical trial," he explains. "Then as soon as the clinical trial is over, they're gone, and they don't give them results or anything."
This type of scenario guarantees that the community will be left hanging, and it leads to resentment and reluctance to participate in future clinical trials.
"We've found that communities that are approached for involvement in clinical trials often feel very disconnected from the enterprise, and there's a lot of paternalism in that realm," Bustillos says. "They don't feel any ownership."
On the other hand, if communities feel from the beginning that they are part of the clinical trial enterprise and process, then they're much more likely to stay in the trial and offer up their participation in subsequent trials, he adds.
One crucial strategy is to form a community advisory board (CAB), Bustillos says.
But it's important to make the CAB more than a board with lip service to the CR enterprise.
"In a lot of studies it seems to us that researchers were going in with preconceived notions of what the problem was and what the answers were," Bustillos explains. "Then they ask for the community's input, but in the process are imposing their needs and telling the community what they want."
Researchers often are unaware of the impact of the power differential and the reality that communities often will bend to the will of the person in the white coat, he adds.
"Often the communities have no input into the research question, and at the primordial stage of a research project they have no input usually," Bustillos says.
"So we involve the community through a CAB and a dialogue-rich and contact-full engagement with the community," he says.
"That's at the design stage," he adds. "Then after the clinical trial is over, we should maintain ties to the community."
This is seldom seen, but it's very important.
"Sometimes in international research, pharmaceutical companies will erect a clinic or have some other lasting presence in the community," Bustillos says. "We'd like to see more of that ongoing engagement with the community after the clinical trial is over."
The lasting commitment to the community's health will go a long way to letting the community know that they're important and the researchers aren't just there to get their data and leave until the next time they need something, he adds.
"Even if it's just a once-a-year health fair, it would be nice to see the academic medical center be there to reassert that they're concerned about the community's health," Bustillos says.
- Eliminating Disparities In Clinical Trials (EDICT). Published by the Baylor College of Medicine and the Intercultural Cancer Center. Available at: www.bcm.edu/edict/PDF/EDICT_Project_Booklet.pdf. Accessed May 5, 2008.