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First Town Hall Meeting on Inequities in Clinical Trials to Take Place at the Harlem Hospital Center on October 20
Date:10/15/2008

Community Leaders/Patients Encouraged to Discuss Challenges; Offer Solutions

NEW YORK, Oct. 15 /PRNewswire-USNewswire/ -- On the heels of a major report revealing that the vast majority of Americans -- and especially women, older people and racial and ethnic minorities -- are either under-represented or completely excluded from the medical studies for diseases from asthma to cancer, Harlem Hospital Center will host a town hall on Monday, October 20 so local leaders, patients, family members and health professionals from the five boroughs can offer their ideas on how to reduce disparities in clinical trials at the community level. The forum will be held in the Herbert G. Cave Auditorium at the Harlem Hospital Center (second floor) from 5 pm to 8 pm.

The first of eight Regional Dialogues to be held in the U.S. and Puerto Rico, the Harlem town hall is part of the EDICT (Eliminating Disparities in Clinical Trials) Initiative, which for the last three years has been advancing solutions so more qualified Americans can take part in important medical studies. EDICT is spearheaded by the Chronic Disease Prevention and Control Research Center (CDPCRC) at Baylor College of Medicine in Houston and the Intercultural Cancer Council (ICC), working to eliminate the unequal burden of cancer among racial and ethnic minorities and medically underserved populations.

Coming at a time when less than one percent of the entire U.S. population -- or an estimated 2.3 million Americans -- takes part in the 80,000 medical research studies conducted every year in the U.S., the Harlem town hall will confront one of the major barriers impeding clinical research: communities are usually left out of the clinical trials process. According to the report issued by EDICT in April 2008, lack of community participation in the clinical trials process is a major reason that the makeup of research studies does not mirror those in the population with the highest rates of disease. For example, EDICT found that less than 10 percent of the patients who participated in clinical trials to test new cancer drugs from 1995 to 1999 were African Americans, Asian/Pacific Islanders, Hispanics and Native Americans.

More than an issue of fairness, EDICT also documented the consequences of not engaging communities in recruiting patients for research studies. According to the EDICT assessment, lack of community participation at the beginning of the process results in mistrust about the purposes of the research study and the sponsoring institution and significantly increases the costs to conduct population-relevant clinical trials and accelerate enrollment into these trials.

"Although investigators and policy makers have debated the reasons for disparities in clinical trials for decades, communities have largely been kept out of this discussion," said Armin D. Weinberg, Ph.D., Director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center and EDICT's Principal Investigator. "Hearing directly from members of the community is needed now if we are going to go beyond simply quantifying the problem to finding practical ways to recruit patients for research studies that reflect all segments of the population."

Providing new insights on one practical solution, participants at the Harlem town hall will focus on increasing the use of clinical trials navigation, a relatively new concept that helps patients navigate within today's complicated healthcare system so they can participate in a clinical trial. Modeled after the "navigator" program created at Harlem Hospital, clinical trials navigation helps patients keep screening and lab appointments and solves their non-medical problems, such as providing child care services. However, according to the EDICT analysis, clinical trials navigation is not currently an accepted standard of practice for institutions conducting human research studies, which is why feedback from community leaders on ways to deliver participant navigation services is needed to increase the use of this important tool.

At the same time, the Harlem town hall will delve into the persistent mistrust of clinical trials and research institutions among African Americans and other minority populations due to the Tuskegee Trial and other past situations of abuse. Forum participants will also focus on improving how information about clinical trials is provided to participants, such as revising overly complicated consent forms, many of which can be in excess of eight pages in length and require a 10th grade reading level.

To address these issues, the Harlem town hall is expected to attract 150-200 community leaders, politicians, disease advocates, patients, and members of the research community as well as many of the foremost medical experts in health disparities from New York and across the country. Among the participants will be: John M. Palmer, Ph.D., Executive Director of the Harlem Hospital Center; Glendon C. Henry, MD, Medical Director of the Harlem Hospital Center; Linda Fleischer, MPH, Senior Director of the Health Communication and Public Health Program at the Fox Chase Cancer Center; Patricia K. Bradley, Ph.D., RN, Assistant Professor at the Villanova University College of Nursing; Angelina Esparza, BA, BSN, RN, Director of Survivorship, Information and Quality of Life for American Cancer Society; Hildy Dillon, Senior Vice President of Patient Services at the Leukemia & Lymphoma Society; Margo Michaels, Executive Director and President of the Education Network to Advance Cancer Clinical Trials (ENACCT); Robert L. Comis, MD, President and Chairman of the Coalition of National Cancer Cooperative Groups; Gayla B. Herschler, MSN, RNC, CCRP, Past President of the Society of Clinical Research Associates; and Venus Gines, M.A., Founder of Dia de la Mujer Latina(TM) Inc.

Also invited to participate are: New York State Health Commissioner Richard F. Daines, M.D.; Commissioner of the New York City Department of Health and Mental Hygiene Thomas R. Frieden, MD, MPH; Congressman Edolphus "Ed" Towns (D-NY) representing Brooklyn and the 10th Congressional District of New York; and Assemblyman Darryl C. Towns, representing the 54th Assembly District in the New York State Legislature.

Eliminating Disparities in Clinical Trials (EDICT) is a four-year initiative (2005-2009) funded with an unrestricted educational grant from Genentech, Inc. to improve participation of minority and underserved patients in clinical trials. In addition to the New York town hall, seven other Regional Dialogues will be held in 2008-2009 in Albuquerque, NM; San Francisco, CA; Honolulu, HI; Tampa, FL; San Juan, PR; Cincinnati, OH; and Morgantown, WV.


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SOURCE Eliminating Disparities in Clinical Trials
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