Using the same process as government agencies when implementing new policies, a national alliance of scientists, public health leaders, and community representatives in March called for public comment on a series of proposals designed to eliminate continued disparities in U.S. clinical trials.

As part of  its four-year EDICT (Eliminating Disparities in Clinical Trials) initiative, a project jointly conducted by Baylor College of Medicine and the Intercultural Cancer Council, the alliance created a new web-based portal so policy makers, patient advocates, research scientists, and industry members can review the proposals developed to improve clinical trials patient recruitment and retention in medical research studies. The project is supported by an unrestricted educational grant from Genentech, Inc.

The public comment period closes on March 21, 2008. On April 1, EDICT will issue its final policy recommendations in Washington, D.C.

"A variety of systemic, cultural, and psychosocial barriers prevent participation by underrepresented populations, including women, adolescents, older adults, racial and ethnic minorities, those with disabilities, [those] in rural areas, and others," said Armin D. Weinberg, PhD, director of Baylor's Chronic Disease Prevention and Control Research Center and EDICT's principal investigator.

As part of the project, more than 300 representatives of public, private, and nonprofit stakeholders catalogued the most significant barriers to participation, examined current policies related to clinical trials, identified opportunities for policy change that would address those barriers, and developed practical and realizable policy solutions to clinical trial disparities at the federal, state, and institutional levels in the public, private, and nonprofit sectors.

"Our policy research has demonstrated the importance of involving the broadest possible set of stakeholders as part of this process. To date, we [have] had input from across all stakeholder groups involved in clinical trials. We are now seeking input from the public at large. We hope that interested individuals and those representing concerned populations will review the policy change recommendations and provide feedback," Weinberg said.

To review the policy recommendations and provide feedback, click here.

According to the EDICT credo:

-- Everyone should have the opportunity and necessary support to participate voluntarily in clinical trials for which they are eligible.

-- Participants and researchers should understand the benefits of diversity in clinical trials.

-- Results from clinical research should benefit the participants' communities and society at large.

Source: PRNewswire 3/3/08

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