Houston, Texas; May 7, 2007 - With mounting evidence that minorities and the poor are the least likely to have access to clinical trials, the U. S. Department of Health and Human Services' (HHS) Office of Minority Health today announced the inauguration of two complementary initiatives designed to accelerate the participation of underserved populations in these research studies.

"The Office of Minority Health is pleased to play a role in this important effort, which will provide new methods and culturally appropriate materials necessary to improve minority participation in clinical trials," said Garth Graham, M.D., deputy assistant secretary for minority health. "Without the adequate representation of racial and ethnic minorities, women and the elderly in these studies, researchers cannot learn about the potential differences among these groups, which are so essential for medical discovery."

In conjunction with leaders from the National Center on Minority Health and Health Disparities and the Office on Women's Health, Dr. Graham announced federal participation in two complementary projects that are among the first to apply National Standards on Culturally and Linguistically Appropriate Services to the clinical trials process. The two projects are CLAS-ACT (Culturally and Linguistically Appropriate Standards And Clinical Trials) and BackPack (a set of tools for researchers).

The projects will be part of a four-year initiative, Eliminating Disparities in Clinical Trials (EDICT), which is conducted jointly by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and the Intercultural Cancer Council, a national organization based in Houston that seeks to eliminate the unequal burden of cancer among racial and ethnic minorities and medically underserved populations.

Intended to provide new recommendations and materials for health professionals by April 2008, the projects will be conducted simultaneously by two separate research teams. Through CLAS-ACT, one research team will develop new guidance so that scientists and health professionals will be able to utilize CLAS standards when designing and recruiting minority patients into new clinical trials. This will be complemented by the BackPack project, which will identify and make available vetted resources, examples, models and policies that will further help those who conduct clinical trials to reduce racial and ethnic disparities in recruitment and retention.

"Culture defines how health care information is received and how patients make choices about their treatment," said Wanda Jones, DrPH, director of the Office on Women's Health. "By understanding, valuing and incorporating culturally and linguistically appropriate standards when designing and recruiting minority patients into new clinical trials, healthcare practitioners and organizations can support a health care system that is truly inclusive and serves the needs of the most vulnerable."

In addition to applying the federal CLAS standards to clinical trials design and recruitment, the new EDICT projects reflect a growing consensus that disparities in clinical trials remain a serious problem for the medically underserved. According to statistics compiled by the Intercultural Cancer Council:

• 88.8 percent of those enrolled in clinical trials between January 2003 and June 2005 were whites, compared to 8 percent who were African Americans, 2.8 percent who were Asians/Pacific Islanders, 0.5 percent who were Native Americans/Alaska Natives and 0.1 percent who were other races. Examining the same data by ethnicity, only 5.6 percent of all patients were Hispanics compared to 94.4 percent who were non-Hispanics;
• Nearly two-thirds of cancer patients are aged 65 years and older. This age group accounts for less than one-third of clinical trial enrollees;
• Regardless of race or ethnicity, low socioeconomic status has a negative impact on clinical research participation.

"From existing data, we know that racial and ethnic minorities, the elderly, those who live in rural areas and the poor represent the smallest percentage of clinical trial participants," said John Ruffin, PhD., director of the National Center for Minority Health and Health Disparities. "Eliminating health disparities in clinical trial design and accrual is therefore a critical goal, which is why these new projects are so significant."

"Without adequate representation of ethnic and racial minorities and other underserved populations in clinical trials, patients suffer and so do researchers, who are hindered in their assessment and generalization of clinical trial results," said Armin Weinberg, PhD, director of the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and co-founder of the Intercultural Cancer Council. "The goal of these projects is to equip researchers, advocates and providers with the tools to affect meaningful change."

The chronic disease program at Baylor develops and applies bio-behavioral research models among culturally diverse, at-risk populations. The Intercultural Cancer Council operates under the auspices of Baylor College of Medicine and is an advocacy organization whose mission is to advance policies, programs, partnerships and research to eliminate the unequal burden of cancer among racial and ethnic minorities and medically underserved populations. EDICT was launched in 2005 with a $5.5 million grant from Genentech, Inc.

For more information, visit www.iccnetwork.org.

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