Women and minorities face barriers to clinical trials

Physicians have great influence over whether minorities and women participate in cancer clinical trials, according to a new literature review.

Women and minorities experience disproportionately high rates of cancer in the United States, yet they are typically under-represented in clinical trials, according to the review in the latest issue of Ethnicity & Disease. Reversing this trend is an important goal of the National Cancer Institute, because study participation is associated with increased survival time and appears to provide both psychological and emotional benefits.

In the report, author Geri L. Schmotzer, Ph.D., of New Mexico State University’s School of Nursing reviewed 22 studies focusing on clinical trial participation and recruitment in under-represented groups including women, ethnic and racial minorities, elderly and/or rural patients, and individuals of low socioeconomic status. She discovered that there are more barriers to participation, both related to the patients themselves and to their physicians, than facilitators.

Among the patient-related barriers for women and minority patients was a reported mistrust of medical researchers and their sponsoring agencies. Other significant barriers include logistical issues such as the time, transportation and expense required for extra study-related clinic visits. “If there were times other than 8 to 5 that people could go to the office and be a part of a research study, that would encourage more participation,” said Schmotzer.

“We need to be more cognizant of the importance of practical barriers and find ways to address and reduce them,” agrees David S. Wendler, Ph.D., an expert on research ethics at the National Institutes of Health Clinical Center. “These likely are more significant than the often-discussed issues of trust and historic abuses.”

Among the reasons offered by physicians for not recruiting more patients for clinical trials was a lack of awareness about available trials. A more troubling finding was that many physicians engage in a form of “triage,” in which they offer study participation to some patients but not to others. They may base this selection process — perhaps unintentionally — on their beliefs regarding the patient’s preferences, anticipated logistical problems, or assumptions about the patient’s ability to understand or comply with study requirements.

“A lot of times the physician makes the decision for the patient prior to even asking the patient,” says Schmotzer. “The failure of a physician to offer a trial due to prior patient triage is inappropriate,” she states in the report.

These findings suggest that more research is needed to understand why physicians may refrain from offering research participation to women and minorities.