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Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific Innovation
Date:4/1/2008

osition of clinical trials, the report reveals that only 25 percent of those taking part in cancer studies in 2003 were over 65 years of age. Older Americans are also routinely left out of clinical trials studying diseases associated with aging, such as Alzheimer's disease, arthritis, and incontinence.

At the same time, the report finds that the biomedical research community has been unsuccessful in resolving the under-representation of women, older adults, and racial and ethnic minorities in clinical research studies, despite many efforts to improve the performance in this area. One study cited in the report that examined the composition of clinical trials testing new cancer drugs between 1995-1999 found less than 10 percent of the patients studied collectively represented African Americans, Asian/Pacific Islanders, Hispanics and Native Americans.

"Although disparities in clinical trials has been discussed and debated extensively, this problem has generally been under-addressed and, as a result, has received little direct, systematic, or sustained intervention," said Armin D. Weinberg, Ph.D., Director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center and EDICT's Principal Investigator. "This report is intended as a nationwide call to action and is provided as a blueprint for removing the barriers to clinical trial participation, which is a critical step to improving the health status of all Americans."

More than an issue of fairness, the EDICT report associates better designed clinical research studies with the increased ability of scientists to catalog and understand the influence of genetic and non-genetic factors on individual and group responses to treatments, now possible as a result of the successful sequencing of the human genome. Findings from the large amount of genetic data generated to date show that more than 90 percent of the observed genetic variations occur within rather than between gro
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SOURCE Eliminating Disparities in Clinical Trials
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