Fear and distrust are hampering efforts to broaden the scope of clinical trials in the US by boosting enrolment from under-represented populations, a new study suggests.

Researchers from the Department of Social Sciences and Health Policy at Wake Forest University School of Medicine used focus-group interviews and guided discussions to explore barriers to trial participation by African-American women and white women of low socio-economic status.

Under-representation of these groups had persisted despite the NIH Revitalization Act of 1993, which asked the National Institutes of Heath (NIH) to ensure women and minorities were included in clinical research, they noted. That in turn limited the ability of medical science to identify mechanisms underlying the continued health disparities between racial/ethnic minority and majority groups in the US or between the socio-economically advantaged and disadvantaged.

A total of 72 women took part in the Wake Forest study, 52 of whom were African-American with a range of income levels and 20 of whom were low-income white women. Three predominant themes emerged across all age groups and in both ethnic groups: fear, distrust and hope.

Fear and distrust were voiced in terms of not wanting to be a ‘guinea pig’ for potentially unethical research – reference was made to the notorious Tuskegee study, in which treatment was deliberately withheld from impoverished black men with syphilis – as well as in concerns about uncovering unexpected diseases or coming to potentially fatal harm.

Concerns over long-term effects

More specific worries related to the long-term effects of treatment, possible complications and side-effects, potential embarrassment and fear of the unknown – including trial participants not knowing whether they were taking a placebo.

Trial investigators were viewed as “self-promoting individuals” who used consent forms to protect themselves from lawsuits and failed to disclose all the elements of, and risks associated with, study participation. Doubts that investigators were telling the full story were especially pronounced in the context of white investigators conducting trials with African Americans.

In addition, a number of practical considerations came into play, such as study duration, frequency of appointments, provisions for child care and discomfort with specific procedures like injections.

Nonetheless, the focus groups also expressed hope that clinical research would help themselves and others in the future, by preventing diseases, finding cures, changing attitudes, advancing knowledge and contributing to new drug approvals.

Trust must be earned

Addressing these conflicting attitudes, the researchers suggested that trust in clinical research “must be earned, especially from members of our society who have long been discriminated against”. It could be improved by “viewing communities as sociocultural entities, developing a network of community leaders, providing outreach services and clear benefits to the community, and including community institutions in the research process”.

Enlisting more African-American and low-income women in clinical research also called for openness and honesty, including dialogue about past abuses, the researchers said.

Participants must be sure the demands of their work and family life were taken into account. Crucially, they must be confident investigators would fully disclose both what the trial required and what would happen to the information obtained. Peter Mansell