Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific Innovation

Wednesday, April 2, 2008 General News
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Report Issued to Improve Policies Affecting How Human Studies Are Conducted

WASHINGTON, April 1, 2008 /PRNewswire-USNewswire/ -- At the same time that medical science is making possible new therapies for treating AIDS, cancer, and other once fatal diseases, a new report finds major shortcomings in the way clinical trials are designed, carried out and funded in the U.S. with serious implications for the outcomes of medical research studies.

The result of the multi-year EDICT (Eliminating Disparities in Clinical Trials) Initiative conducted by the Chronic Disease Prevention and Control Research Center (CDPCRC) at Baylor College of Medicine in Houston and the Intercultural Cancer Council (ICC), the report provides an in-depth assessment of the state of clinical trials in the U.S. and offers a nine-step action plan for improving the relevant policies of public, private and non-profit sponsors of clinical trials that affect how human studies are conducted.

Among the deficiencies cited are the exclusion or under-representation of women, older people and minorities in the vast majority of human research studies; insufficient training in disparities for members of institutional review boards (IRBs), who by law, must review the protocols for all clinical studies; and the duplication of effort in the diseases studied by government and private industry, resulting in insufficient attention and resources for diseases where there are significant disparities in outcomes and high case fatality rates.

Because identifying potential differences among groups treated with a therapeutic regimen is an important goal of human studies, the EDICT review singles out the under-representation of women, older people, minorities, disabled persons, and rural populations in clinical trials as the problem requiring immediate attention and change at a systemic level. Looking specifically at cancer clinical trials where a lot has been published about the composition 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 pe

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