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Too Many Minority Kids in Studies?

Minority Children May be Overrepresented in Clinical Trials

Oct. 7, 2003 -- Although too few minority adults are included in medical research, a new study shows that minority children may actually be overrepresented in medical research, including potentially life-saving clinical trials.

Researchers found that African-American children are currently overrepresented in medical research, but white and Hispanic children are underrepresented.

The study, published in the October issue of Pediatrics, suggests that "black children do have fair access to the potential benefits of clinical trials" despite having less access to quality health care in general.

But researchers say that being overrepresented in medical research may not always be advantageous. For example, they found that a greater proportion of minority children were involved in potentially stigmatizing research such as studies of child abuse, high-risk behaviors, or HIV.

The Pendulum Swings on Clinical Trials

Researchers say that when officials first began looking at the issue of fairness in selecting subjects for medical research and clinical trials, the major concern was ensuring fairness in the distribution of risks. A 1977 federal report recommended that research first be done on animals, and then on adults, and only afterward on children in order to protect them from potential risks.

But by 1994 the pendulum had swung in the other direction, and the focus in recent years has been in fair distribution of the benefits of participation in medical research.

Clinical trials, especially those in the final, phase III stage now often offer the best chance of recovery for many conditions, and officials feel exclusion from phase III clinical trials may put certain populations at a disadvantage. A clinical trial is a research study in human volunteers that answers specific health questions on the safety and effectiveness of new drugs or devices or of behavioral intervention.

Children in Medical Research

To measure minority participation in medical research involving children, researchers looked at all the articles published in three major pediatric research journals from July 1999 to June 2000. They found 128 articles that included data on race and ethnicity, and the number of participants ranged from eight to 6,982, for a total number of participants of 58,413. They then compared the percentages of racial and ethnic groups to U.S. census data. Medical research is design to develop or contribute to knowledge.

Researchers say they were surprised to find that black children were, in fact, overrepresented in clinical research. African-Americans make up 15% of the U.S. population, but 26% of children involved in medical research were African American, and 32% of those enrolled in clinical trials.

But although 69% of the U.S. population is white, only 54% of children in medical research were white, and 52% of those in clinical trials.

Researchers also found enormous inconsistencies in how race and ethnicity were reported in studies, and reporting of Hispanics was particularly varied and unreliable. Overall, the study showed that Hispanic children and their parents were underrepresented in medical research, but researchers say the data may be inaccurate.

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