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Limiting Eligibility for Medical Studies can Omit Women and African-Americans

design their studies to ensure adequate enrollment of all populations, including women and racial minorities.

"The NIH, and we as a society, have decided that the burden and benefits of health research should be shared by everyone," said Humphreys, who is also on the staff of the Veterans Affairs Palo Alto Health Care System. "It's a moral and political stance and we're obligated to live up to it."

For the analysis, Humphreys and his colleagues looked at data sets from five previous alcohol treatment studies that enrolled more than 100,000 patients. They then explored the impact of six exclusion criteria commonly used in treatment outcome research: psychiatric problems, neurological problems, medical problems, drug use, non-compliance issues, and social and residential instability.

The researchers found that women were 62 percent more likely than men to be disqualified from studies that required social and residential stability. Women were 29 percent more likely to be excluded from studies that disqualified patients with psychiatric problems, and 20 percent more likely to be excluded for medical problems.

They also found that African-Americans were 46 percent more likely than non-African-Americans to be excluded from studies that required social and residential stability, and 23 percent more likely to be excluded based on drug-use criteria.

"The end result can be a sample that over-represents Caucasian males relative to the treatment population," the authors noted in their paper.

Humphreys stressed that he doesn't believe his fellow researchers are acting out of prejudice or purposefully excluding patients. "Most researchers want women in the studies, but they don't realize that the way they design the study undermines their intentions," he said. "A researcher may say, 'I don't want anyone who is depressed in my alcohol study,' and not stop to consider that the majority of depressed people are w
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