Minorities wary of vague clinical trials

Blacks and Hispanics are 80% more likely than whites to fear participating in biomedical research, a new study shows. That disparity disappeared, however, when respondents were asked about their willingness to take part in particular study activities such as giving blood or taking medications.

The November Journal of Health Care for the Poor and Underserved features results of a 60-question survey of 900 adults in four U.S. cities aimed at measuring the legacy of the U.S. Public Health Service Syphilis Study at Tuskegee. In the notorious study that took place between 1932 and 1972, 400 black Alabama sharecroppers with syphilis were denied medical treatment so researchers could observe the disease's long-term course.

Minority participation in biomedical research studies has long trailed that of whites, despite a 1993 federal law mandating inclusion of women and minorities in clinical trials sponsored by the National Institutes of Health. Many researchers have speculated that the Tuskegee tragedy played some role in discouraging minority participation, but that view "wasn't an intellectual realization," according to Ralph V. Katz, DMD, PhD, MPH, lead author of the study. "It was an emotional assumption."

To better understand attitudinal differences of blacks, whites and Hispanics, Dr. Katz and his co-authors crafted two sets of questions. First, the "guinea pig fear factor" scale asked respondents about how likely it was that privacy concerns, finances, mistrust, fear of contracting AIDS or fear of being a "guinea pig" would interfere with their taking part in a medical study. On this scale, both blacks and Hispanics were 80% more likely to say such concerns would give them pause.

Next, a "likelihood of participation" scale asked respondents a generic question about how likely they would be to participate and also how different activities such as undergoing surgical procedures or taking IV injections might influence their views. It also asked whether the medical research sponsor -- one's own doctor, for example, versus a medical school -- mattered. On this scale, there were no differences between whites, blacks and Hispanics.

This latter scale is "more true of reality," said Dr. Katz, chair of health and epidemiology at New York University College of Dentistry. "You don't say, 'Will you join any study?' You say, 'Will you join my study?' Someone specific is asking them, and what they're being asked to do is known. At first blush, minorities "have a little more trepidation, a little more wariness," Dr. Katz said, adding that "every trial is made up of specific requests. It's clear that the details matter."

Nancy R. Kressin, PhD, a co-author on the study, said previous research shows that factors in addition to the so-called Tuskegee legacy reduce minority participation in clinical trials.

"There are some fundamental logistical barriers that influence minorities and especially those of lower socioeconomic strata," said Dr. Kressin, associate professor of general internal medicine at Boston University School of Medicine. "These are people who have less time, less money and more hassles in life to overcome to participate."

"To realize that even today people of color are still somewhat suspicious, and this seems to be in part related to the Tuskegee syphilis study, makes it clear that clinicians need to work harder to gain the trust of patients of color," Dr. Kressin said.