Major Deficiencies in Design; Funding of Clinical Trials Affects Future of Scientific ... (arriers toclinical trial participation e...)

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

Date:4/1/2008

arriers to clinical trial participation exist at every level, requiring immediate and longer-term policy change. Towards this end, the EDICT report calls for implementation of a series of practical and realizable policy solutions to clinical trials disparities in the following areas:

1. Implement regulatory changes to improve the way research trials are designed and conducted. The report calls on the Food and Drug Administration (FDA) to harmonize its policies so they are consistent with the NIH Revitalization Act of 1993, thereby mandating to require appropriate inclusion of under-represented populations in all clinical trials conducted to bring new drugs and devices to the market. EDICT team also advocates expanding the application of the federal government's CLAS (Culturally and Linguistically Appropriate Services) standards in clinical trials as a necessary step to improve the way government-sponsored research is designed and conducted.

2. Increase the collaboration between government and industry in the design and implementation of clinical research. Because nearly 75 percent of the funding for clinical trials comes from industry sponsors, new initiatives that attract more women, older people, minorities, and rural populations into research studies are needed to ensure the generalization of results. This will entail creating new regulatory incentives for pharmaceutical industry trials to include underrepresented populations, as well as imposing penalties for non-compliance with federal policy on appropriate inclusion.

3. Foster community involvement in clinical trials. Today, community organizations are usually left out of the clinical trials process, resulting in increased costs and additional resources for investigators to conduct population-relevant clinical trials and secure enrollment into these trials. Towards this end, the EDICT team recommends that investigators build a detailed plan for community engagement into the research prot
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SOURCE Eliminating Disparities in Clinical Trials
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