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Conflicting Attitudes Hinder Participation In Clinical Trials

Date:
February 16, 2007
Source:
Wake Forest University Baptist Medical Center
Summary:
Women have conflicting attitudes about participating in clinical trials because of uncertainties about trusting the experimenters, fear of the trial itself and hope that the research will result in medical progress, according to a new study at Wake Forest University School of Medicine.

Women have conflicting attitudes about participating in clinical trials because of uncertainties about trusting the experimenters, fear of the trial itself, and hope that the research will result in medical progress, according to a new study at Wake Forest University School of Medicine.

Researchers in the Department of Social Sciences and Health Policy said in the February issue of the Journal of Health Care for the Poor and Underserved that they especially focused their research on black women and low socio-economic status white women.

"Enrolling representative populations is essential to the generalizability of study findings," wrote the team -- Deborah F. Farmer, Ph.D., Sharon A. Jackson, Ph.D., and Mark A. Hall, J.D. The researchers noted that Congress mandated including women and minorities in clinical trials in 1993, yet women and minorities continue to be under-represented.

"The results of our study demonstrate the willingness of at least some African-American and low socioeconomic status white women to participate in research if it will benefit them or their families, advance scientific knowledge and help others in the future," they wrote. "But they must trust the researchers to be ethical and upfront with them about what is required, fully disclose what will happen to the health information they provide, and put their best interests first."

The Wake Forest team enrolled 72 women -- 52 black women from a range of income levels and 20 low-income white women -- and placed them in 10 focus groups. Three themes emerged from analysis of the focus group discussions -- fear, distrust and hope.

"The attitude of fear was expressed in terms of not wanting to be a guinea pig or doing something that no one has done before," the team wrote. The women also recalled the Tuskegee Syphilis Study, in which black men went untreated even after effective treatment for syphilis became available.

(According to the Centers for Disease Control and Prevention, "The Tuskegee Syphilis Study, carried out in Macon County, Ala., from 1932 to 1972, is an example of medical research gone wrong. The U. S. Public Health Service, in trying to learn more about syphilis and justify treatment programs for blacks, withheld adequate treatment from a group of poor black men who had the disease, causing needless pain and suffering for the men and their loved ones.")

In the focus groups, distrust of investigators also emerged, viewing them "as self-promoting individuals who use consent forms to protect themselves against lawsuits and who do not disclose all facets and risks associated with study participation."

On the other hand, "participants expressed hope that research would help them and others in the future prevent diseases, find cures, change attitudes and lead to advances in knowledge and the eventual approval of new drugs," the researchers say in the article. That was especially true for health conditions that affected them or their families.

The women listed a number of other reasons for not participating in clinical trials: "location of the study, time of day that the study was held, duration and time commitment of participation, availability of parking, and provision of child care."

The women also feared finding out they had a disease as a result of tests and medical procedures done as part of the study.

The researchers added, "Participants also expressed fears and worries about the long-term effects of treatment, possible complications and side effects, embarrassment, fear of the unknown and even the possibility of death.... They also expressed uncertainty about study medications and not knowing whether they were on a placebo, the possibility that the medicine might not work for them, and the strong feeling they didn't want to be experimented on."

Participants also took a physician trust scale. Older women had significantly higher trust scores than younger women. Trust scores did not vary by ethnicity.

To counter the negatives, the researchers called for greater involvement of academic medical centers with minority or low socioeconomic status communities where they could become partners in research to address health problems and concerns of the community. They noted, "This type of research partnership takes time to establish and maintain."

Hall is professor of public health sciences and professor of law. Farmer is now assistant professor of gerontology in the Department of Social Sciences at Winston-Salem State University, and Jackson is now a contractor for Northrop Grumman assigned to the Centers for Disease Control and Prevention in Atlanta. Another member of the research team was Fabian Camacho, M.S., of Wake Forest. The study was paid for by a grant from the Women's Health Center of Excellence at Wake Forest.


Story Source:

The above story is based on materials provided by Wake Forest University Baptist Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

Wake Forest University Baptist Medical Center. "Conflicting Attitudes Hinder Participation In Clinical Trials." ScienceDaily. ScienceDaily, 16 February 2007. <www.sciencedaily.com/releases/2007/02/070201093616.htm>.
Wake Forest University Baptist Medical Center. (2007, February 16). Conflicting Attitudes Hinder Participation In Clinical Trials. ScienceDaily. Retrieved September 23, 2014 from www.sciencedaily.com/releases/2007/02/070201093616.htm
Wake Forest University Baptist Medical Center. "Conflicting Attitudes Hinder Participation In Clinical Trials." ScienceDaily. www.sciencedaily.com/releases/2007/02/070201093616.htm (accessed September 23, 2014).

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