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

sparities in outcomes and high case fatality rates. Addressing this problem will require an honest broker to access areas of duplicative research, which is why EDICT recommends that the Institute of Medicine conduct a new study that will recommend strategies for eliminating duplication and promoting coordination. Based on this assessment, Congress will be able to ensure that federal research funding complements private sector funding and gives priority to diseases with the greatest disparities and the highest case fatality rates.

7. Enhance public education about clinical trials. Lack of awareness about clinical trials, fear or mistrust of medical research, and the complexity of consent forms and other clinical trials materials are major barriers to patient accrual. Accordingly, the report calls for the widespread development and implementation of culturally appropriate recruitment and retention plans with an additional focus on community education provided in appropriate languages for non-English and limited-English speaking populations.

8. Implement participant navigation as a critical element of the clinical trials process. Modeled after the "navigator" program created at Harlem Hospital, patient navigation is a new tool that helps patients keep their appointments and solves their non-medical problems. Because of its potential to retain patients in medical research studies, an analogous process termed "participant navigation" should become the accepted standard of practice for institutions conducting clinical trials.

9. Assure insurance coverage of the costs associated with clinical trials. The costs associated with participating in a clinical trial are a concern to all patients and have remained a major barrier to patient accrual. Addressing this problem will require actions by both policy makers and the business community to identify and close any existing gaps and to produce and disseminate easy-to-understand information about what the ins
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SOURCE Eliminating Disparities in Clinical Trials
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