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

ups. This underscores the fact that ethnicity -- which incorporates multiple variables including genetics, economic, social, dietary, religious, and linguistic background -- has biomedical consequences when studying health outcomes.

Accordingly, the EDICT report identifies a number of behavioral, social, economic, medical, and policy-related factors that must be addressed if the biomedical research community -- government researchers, academic centers and other non-profit sponsors, and industry scientists -- is to meet the complex healthcare needs of an ever more diverse U.S. population. Among the factors singled out for corrective action are:

-- Strict inclusion or exclusion eligibility criteria that excludes patients who have co-morbidities, those who speak languages other than English, and subjects over a certain age;

-- Lengthy and complex consent forms and other clinical trials materials that are difficult to read and are printed only in English;

-- Vague information about how Medicare, Medicaid and private health insurers reimburse for the routine costs associated with being in a clinical trial;

-- Insufficient training for institutional review boards (IRBs), which results in the systematic approval of research protocols that do not provide for inclusion of underrepresented populations;

-- Divergent federal policies about the level of participation of racial and ethnic groups in government-sponsored clinical trials; and

-- A significant duplication of effort in the diseases studied by government and private industry sponsors, resulting in insufficient attention and resources for diseases, such as liver and kidney cancers, where there are significant disparities in outcomes and high-case fatality rates.

The report, prepared through a collaborative process involving more than 300 representatives of public, private and non-profit stakeholders who worked in teams over several years, finds that extensive b
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SOURCE Eliminating Disparities in Clinical Trials
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