
A report in Baltimore Sun states that early clinical trials "tend to enroll relatively healthy white males but few children, women, minorities and older patients" -- a disparity that can result in research that "ignores biological differences that cause people of varying ages, genders and ethnicities to react differently to therapies."
Early clinical trials "tend to enroll relatively healthy white males but few children, women, minorities and older patients" -- a disparity that can result in research that "ignores biological differences that cause people of varying ages, genders and ethnicities to react differently to therapies," the Baltimore Sun reports.
According to the Sun, "therapies that perform well in clinical trials often prove less effective -- and sometimes more dangerous -- when put to widespread use," according to the Sun. In addition, some trials might not show any benefits for white males, but the therapies might be helpful to minorities.
According to experts, women of childbearing age are reluctant to participate in clinical trials because of possible harm to developing fetuses, while blacks "tend to be generally more distrustful of the medical establishment than other groups," and older patients are more likely to have multiple conditions, complicating the results of the study, the Sun reports.
The sampling problem "puts the FDA, Medicare and private insurers in the difficult position of using narrowly focused data to decide which drugs will be used in a broad population of patients," according to the Sun. Congress in 1993 passed a law that encourages federally funded trials to include women and minorities, and FDA has begun encouraging companies to report gender- and race-specific trial data.
Terry Eigo, director of the FDA's Office of Special Health Issues, said, "The message is that we encourage diversity in research." She added that the agency does not mandate sampling diversity because if it "required substantial numbers of people in every subgroup, the size of the trials would be massive," and it is "likely that the benefits would not be worth the cost".
Source: Kaiser Family Foundation
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