In the three years since Congress passed the Food and Drug Administration (FDA) Safety and Innovation Act of 2012 with its provision encouraging the inclusion of minorities in clinical trials, IRBs and research sites have continued to struggle with the need to diversify study participant pools.
The human research protection community is working harder now than ever to include historically underrepresented populations in clinical trials. Efforts to improve recruitment of minorities and women in clinical trials were boosted by requirements of inclusion spelled out in the National Institutes of Health Revitalization Act of 1993.
But there have been multiple barriers to success, including scars from past research wrongs visited on particular racial and ethnic groups, as well as potential participants’ lack of research knowledge and health literacy.
Clinical trial recruitment is time-consuming and costly — especially when research organizations focus on recruiting in underrepresented populations. “We don’t have the resources to do this correctly,” says Amelie G. Ramirez, DrPH, MPH, professor and interim chair of 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.
“Reaching out to our minority audiences requires increased information about clinical trials and how they can benefit from them, and it also requires us to be language-specific and to reach members of a population where they are,” Ramirez adds.
For instance, Ramirez has found that many people from minority communities are suspicious of clinical trials and are uninformed about how research can improve life for everyone.
“I deal with the Hispanic population,” Ramirez says. “And what I hear most from people is, ‘I don’t want to be treated like a guinea pig.’”
Research programs want people to know how their involvement in clinical trials can help people in the future, but this message needs to be clarified for many people, including those in minority communities, she adds.
Additional obstacles for many Hispanic cancer patients has been that they often come into treatment in later stages of their disease — sometimes too late for inclusion in a clinical trial, or their disease is an orphan cancer, Ramirez says.
“When patients come in so late in the disease [process], it’s really difficult and we don’t have any options for them,” she explains. “Also, we have in the Hispanic population a lot of orphan cancers, and there is no treatment, much less clinical trials.”
Recruiting study participants is particularly challenging when the goal is to reach a representative proportion of racial and ethnic minorities, says S. Azor Hui, PhD, MSPH, research scientist with Public Health Management Corp. in Philadelphia.
Hui conducts cancer prevention research, including a recent study that looked at a new way to increase participation rates in cancer prevention trials. Because racial and ethnic minorities are underrepresented in cancer prevention trials and novel recruitment strategies are necessary, the study looked at whether at-risk individuals are interested in a new way of identifying higher cancer-risk individuals and recruiting them into cancer clinical prevention trials.1
“In my study about the interest and willingness to engage in this new recruitment method, I had to restrict the number of white participants because we wanted to oversample racial and ethnic minority participants,” Hui says. (See story on strategies for recruiting minority trial participants in this issue.)
Clinical trial work is an extremely important tool that is necessary to advance scientific discovery, but it needs to be as widely available as possible to be effective, says Sandra E. Brooks, MD, MBA, chief medical officer of CompleteCare Health Network in Bridgeton, NJ.
In cancer research, there have been some success stories involving minority recruitment, particularly with breast cancer trials that have used targeted strategies to recruit underrepresented minority women, Brooks says.
“They developed a special outreach effort, identifying multiple sites to recruit patients, provided tools for sites to use and staff to help determine eligibility,” Brooks explains.
Targeted outreach strategies work, but they take time and resources. In some minority communities, these strategies must be preceded by trust-building efforts, she says.
“We need to develop a level of engagement with communities that might be at risk for a certain condition, and develop trust overall from a cultural and health literacy perspective,” Brooks says. “Within that context, we can talk about clinical trial recruitment.”
For example, one research organization in Louisiana tested a variety of minority recruitment strategies, including working with community groups, forming a community advisory board, partnering with different churches, and having experts talk with the community about how the disease being studied was affecting their community, she says.
These efforts proved to be successful, Brooks adds.
While these types of minority recruitment efforts can work well, they require funding and require a high level of institutional commitment, she notes.
“Some of our challenges are having the infrastructure to open up enough trials for patients,” Brooks adds. “Sites tend to have higher rates of enrollment when they have a higher level of infrastructure or are dedicated to physician and data management support.”
In research about enrollment in gynecological cancer trials, Brooks and co-investigators have found that non-white patients and patients of African-American physicians were more likely to enroll in trials.2
“Our African-American doctors enrolled patients at very high rates irrespective of the patient’s race,” Brooks says. “While our study was not designed to explore the reasons for those findings, we determined that the perception of the patient’s interaction with the healthcare team was important.”
Trust mattered: “If patients felt that their physician wanted them to go on the trial, then they were more likely to go on the trial,” Brooks says. “If they felt pressure to enroll in a trial, they were less likely to go on the trial.”
Brooks also was involved in a clinical research paper that concluded that U.S. research organizations will need to engage in specialized training and adopt effective and efficient recruitment strategies to increase minority enrollment and maintain world leadership in cancer care innovation and delivery.3
“The goal is to improve participant accrual overall, but specifically to support organizations that that are employing successful strategies in settings with high percentages of minority patients,” Brooks says. “We also need a diverse group of physicians who are very dedicated to talking with patients about clinical trials and doing what’s required to have a clinical trial program.”
The FDA has heightened focus on minority participation in clinical trials in recent years as a result of the 2012 Safety and Innovation Act, says Jonca Bull, MD, assistant commissioner for minority health at the FDA.
Section 907 of the 2012 FDA law, required the FDA to develop a report on the extent that subgroups of women and minorities are included in applications for biologics and devices. Section 1138 requires the FDA to ensure adequate information about pharmaceuticals is available for all populations, but especially for underrepresented subpopulations and racial subgroups.
“Based on findings of that report, the FDA developed an action plan addressing whatever gaps or deficiencies are identified,” Bull says. “Also, the FDA was asked to look at the existing framework and guidance and their adequacy to helping provide broad, meaningful participation of groups that are critical for a full and complete and thoughtful analysis of medical and safety efficacy.”
The FDA’s report and resulting action plan identified the following three priority areas:
1. Improve the quality of data submitted to the FDA. “The report found that there was a lot of inconsistency in how commercial sponsors submitted data from populations in the trials,” Bull explains. “For example, there might be differences in prevalence of disease in particular subgroups or differences in the course of a disease.”
The goal of this priority area is to give clinicians the information they need to make decisions that affect all patients’ health, Bull adds.
2. Raise awareness of clinical trials to increase participation. Making changes, including raising awareness of clinical trials, will require a sustained engagement by the research industry in working with patients, she notes.
3. Increase transparency around the data. The FDA publishes a consumer update that provides subgroup information in an accessible format, Bull says.
“Another issue that was deliverable under the law is an agreement from the FDA to convene meetings about patient-focused drug development,” Bull says. “The FDA has agreed to do a minimum of 20 of these meetings across diseases.”
REFERENCES
- Hui SA, Miller SM, Hazuda L, et al. Novel method for recruiting representative at-risk individuals into cancer prevention trials: online health risk assessment in employee wellness programs. J Cancer Educ. 2015:Oct. 27. Epub ahead of print.
- Brooks SE, Carter RL, Plaxe SC, et al. Patient and physician factors associated with participation in cervical and uterine cancer trials: an NRG/GOG247 study. Gyn Onc. 2015;138:101-108.
- 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.
In the three years since Congress passed the Food and Drug Administration Safety and Innovation Act of 2012 with its provision encouraging the inclusion of minorities in clinical trials, IRBs and research sites have continued to struggle with the need to diversify study participant pools.
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