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

ocol that includes demonstrated methods and measures for working with community organizations and institutions.

4. Implement new policies so that peer-reviewed medical/science journals addressthe issue of the representation of trial subjects in clinical research studies. Although peer-reviewed medical/science journals have addressed significant issues where increased attention by the scientific community is warranted, the discussion of diversity, inclusion and representation in clinical trials has been missing from published studies. To change this situation, the EDICT team is calling on two chief editorial organizations for biomedical publications -- the International Committee of Medical Journal Editors (ICJME) and the World Association of Medical Editors (WAME) -- to adopt standards that require investigators to include in their manuscripts an analysis of how the subject population's demographics correspond to those of the population that bears the greatest disease burden.

5. Invest in specialized training for Institutional Review Boards. Although the mission of institutional review boards (IRBs) is to safeguard the rights, safety, and well being of all human research participants, IRB members often lack the training needed to recognize disparities, and thus regularly approve research protocols that do not provide for inclusion of under-represented populations. Accordingly, an important priority is to work through the HHS Office of Human Research Protections (OHRP), which oversees the regulation of IRBs, and the Association for the Accreditation of Human Protections Programs (AAHRPP) to add specific requirements that IRBs receive training in healthcare disparities.

6. Reallocate research funding to avoid duplication and address disparities. The report reveals a major duplication of research efforts in some disease categories and insufficient attention and resources for diseases, such as liver and kidney cancers, where there are significant di
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SOURCE Eliminating Disparities in Clinical Trials
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