Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific ... ( Report Issued to Improve Policies...)

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

Date:4/1/2008

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 comp
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