Investigators and IRBs are finding a variety of ways to increase minority representation in studies and clinical trials, including policies mandating such recruitment.

One academic center IRB requires studies to reflect the community of patients they serve, says Jonca Bull, MD, assistant commissioner for minority health at the FDA.

“The IRB was firm that studies have a representative population for that particular community,” Bull says.

One way to interpret an IRB’s mission to ensure human subject safety and protection is to make certain research studies have enrolled people who represent the groups affected by the condition or disease. Studies must have sufficient information about all of the populations affected by a disease in order to accurately characterize benefits and risk, Bull says.

Another strategy for improving minority recruitment in trials is for research organizations and IRBs to make certain recruitment strategies are outlined in grant and IRB applications, says Sandra E. Brooks, MD, MBA, chief medical officer of CompleteCare Health Network in Bridgeton, NJ. Brooks and co-investigators have studied barriers to clinical trial enrollment among minority populations and the general population.

“In our study, clinical trials are available for just 38% of patients,” Brooks says. “Physician specialty, ethnicity, practice type — hospital-based or academic — and the presence of data management were associated with availability of trials.”

In Brooks’ research, investigators found that patients were more likely to enroll if they felt the trial would help them and if they felt their doctor wanted them to go on the trial or if they were concerned they might not receive the best care if they didn’t go on the trial.

“They were less likely to enroll if they felt pressure to enroll or if they were providing nonpaid care to someone, which speaks to patients’ other commitments,” Brooks notes.

In a recent paper, Brooks and other researchers outlined some of the strategies for increasing minority enrollment in clinical trials, including the following1:

  • Researchers can use novel trial designs that naturally create subgroups from larger disease populations and that include diverse subgroups in the trial design phase.
  • Investigators must be culturally sensitive and aware of the effect of appropriate communication and patient trust and be able to encourage clinical trial participation among diverse groups of patients.
  • Advertising and research enrollment information should be more widespread and include collaboration with community groups, survivor advocacy groups, churches, and other local institutions.1

Not all studies are appropriate for focused minority recruitment, but with diseases such as breast cancer that affect subpopulations differently, it’s important to have research participants from those subpopulations, Brooks explains.

“As part of the IRB review, there could be a way to address how recruitment of subpopulations is approached,” she adds. “I think the importance of minority recruitment is gaining more visibility, and the National Cancer Institute has supported these efforts for some time, but there’s still a long way to go.”

When researchers make it a priority to improve minority recruitment, they might consider novel strategies instead of relying on traditional advertising and outreach.

For instance, researchers conducting a cancer prevention trial could work with employee wellness programs to reach a demographically representative population of at-risk people, suggests S. Azor Hui, PhD, MSPH, research scientist with Public Health Management Corp. in Philadelphia.

“In the past few decades, employee wellness programs have become more and more popular,” Hui says.

Such programs typically have online health risk assessment (HRA), including questions about cancer risk. So this information can be used to identify people who could be enrolled in cancer prevention trials, she explains.

“So my proof of concept study proposed using online HRA to link these individuals into cancer prevention trials through an electronic health information transfer system,” Hui says. “If someone says they’re interested in participating in a cancer prevention trial that might benefit them personally, they can click a link that says, ‘I release my health risk assessment responses.’”

The information then goes to an external, secure database where a specialist can view the individual’s profile and see whether they could participate in a trial. If there is a trial that could fit, the specialist could proactively call the at-risk individual to discuss in more detail about what’s involved in participating in the trial, Hui adds.

This type of recruitment outreach has the potential reach to a proportionate number of racial and ethnic minorities, as well as a general population. This would be a great improvement over current cancer prevention trial enrollment, which is 80% to 90% white or Asians and vastly underrepresent African-Americans and Latinos, Hui explains.

“Using a workforce population can produce more minorities for studies,” she adds.

All strategies for improving minority recruitment in research should begin with better public education about clinical trials, suggests Amelie G. Ramirez, DrPH, MPH, professor and interim chair for the department of epidemiology and biostatistics, director of the Institute for Health Promotion Research, and associate director for population sciences for the CTRC Cancer Center at the University of Texas Health Sciences Center in San Antonio.

“When patients come into a clinic and are told they can participate in a clinical trial, it can’t be the first time they hear of it,” Ramirez says.

“We have found that it helps to use outreach community health workers, particularly for Phase III trials where you’re trying to recruit large groups of participants,” she adds.

Outreach community health workers explain research to patients and provide information about particular studies.

Education also is needed for physicians, who sometimes will not offer trials to minority populations based on a belief that the studies are too complicated or because the patients might need transportation or have insurance problems that could prevent them from making appointments, Ramirez says.

“We need to help clinicians have an appropriate resource team behind them so that everyone who is eligible is offered to participate,” she adds.

Another strategy involves a computer-based program for educating people about clinical trials.

“Right now, we’re testing a methodology where we’re informing patients before they’re offered a clinical trial what it’s about,” Ramirez says. “We show vignettes of people of different ethnic backgrounds who went through these stages of participation, and at the end the person has a more personalized approach to clinical trials.”

Although research is ongoing, preliminary data show the need for additional outreach and educational resources to sustain recruitment of minority populations, Ramirez says.

“We also need trials for some of the orphan cancers that are not as prevalent in other population groups,” she adds.

For example, Hispanics have lower rates of breast cancer and prostate cancer than other populations, but Hispanic children have higher rates of leukemia and there are orphan cancers affecting the population. Overall cancer rate for Hispanics is expected to increase by nearly 200% by 2050, she says.

REFERENCE

  1. Brooks SE, Muller CY, Robinson W, et al. Increasing minority enrollment onto clinical trials: practical strategies and challenges emerge from the NRG Oncology Accrual Workshop. JOP. Oct. 13, 2015:1-5.