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Overcoming Diversity Obstacles: A Clinical Imperative

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Product Description

The Human Genome Project, research into responses to medicine, even the results of several clinical trials indicate that race and ethnicity do have bearing on the safety and efficacy of pharmaceuticals. Consequently, it is critical that pharmaceutical companies, CROs, and investigators ensure that a diverse selection of patients are represented in clinical trials.
Both the Food and Drug Administration and the National Institutes of Health in the mid-1980s began to look at policies for inclusion of women, and then minorities, in clinical-trial research. In 1997, the Food and Drug Administration Modernization Act (FDAMA) directed the FDA to examine issues related to the inclusion of racial and ethnic groups in clinical trials of new drugs.

Sidebars:
Leading Causes of Death for African Americansin the United States in 2000
Under-Represented Populations — Targets for Research
Face of America — Population Trends
A Plan of Action
Diversity and the Bottom Line

Experts on this Topic
Diana L. Anderson, Ph.D. President and CEO of D. Anderson & Co., Dallas; D. Anderson combines clinical-trial experience and site management services with media and communication expertise aimed at accelerating clinical-trial outcomes. For more information, visit dandersoncompany.com. Dr. Anderson also is chairman of the board of trustees of the Association of Clinical Research Professionals (ACRP), Alexandria, Va.; ACRP is an international membership organization that represents more than 17,000 clinical research professionals from diverse organizations. For more information, visit acrpnet.org.
Lynn Baer. Senior Director and Head of Clinical-Trial Operations, Novo Nordisk Pharmaceuticals Inc., Princeton, N.J.; Novo Nordisk A/S is a world leader in diabetes care, with a broad diabetes product portfolio, including some of the most advanced products within the area of insulin delivery systems. For more information, visit novonordisk-us.com.
Kenneth M. Borow, M.D. President and CEO, Covalent Group Inc., Wayne, Pa.; Covalent is a clinical research organization that designs and manages complex clinical trials for the pharmaceutical, biotechnology, and medical-device industries. For more information, visit covalentgroup.com.
Jucinda Fenn-Hodson. VP of Multicultural Marketing, Palio Communications, Saratoga Springs, N.Y.; Palio is a full-spectrum, strategically driven advertising and communications company. For more information, visit paliocommunications.com.
Sarah Harrison. VP, customer strategy integration, AstraZeneca, Wilmington, Del.; AstraZeneca is an international research-based pharmaceutical company engaged in the development, manufacture, and marketing of prescription pharmaceutical products. For more information, visit astrazeneca-us.com.
Edward F. Ikeguchi, M.D. Chief Medical Officer and CoFounder, Medidata Solutions Inc., New York; Medidata streamlines how organizations collect, verify, and report clinical-research data, reducing the cost and time required to complete research programs. For more information, visit medidatasolutions.com.
Deborah Kniuksta. Assistant Director of Patient Recruitment, Kendle International Inc., Cincinnati; Kendle is a global provider of clinical development, regulatory/validation consulting, and medical communications services to the pharmaceutical and biotechnology industries. For more information, visit kendle.com.
Michael LeNoir, M.D. Principal Investigator for the National Medical Association’s clinical-trial’s program, Project Impact, Washington, D.C.; The NMA promotes the collective interests of physicians and patients of African descent by serving as the collective voice of physicians of African descent and a leading force for parity in medicine, elimination of health disparities, and promotion of optimal health. For more information, visit nmanet.org.
Liz Moench. President, MediciGroup Inc., King of Prussia, Pa.; MediciGroup was founded in 1993 with the vision of building long-term client relationships by providing innovative direct-to-patient clinical-trial recruitment and retention programs. For more information, visit medicigroup.com.
Lucille C. Norville Perez, M.D. Past President, National Medical Association, Washington, D.C.; The NMA promotes the collective interests of physicians and patients of African descent by serving as the collective voice of physicians of African descent and a leading force for parity in medicine, elimination of health disparities, and promotion of optimal health. For more information, visit nmanet.org.
Thomas Schnitzer, M.D., Ph.D. Chairman of the board of RRI, Dallas; RRI provides comprehensive rheumatology services ranging from extensive site management and patient recruitment to marketing. For more information, visit rri.net.
William Sietsema. VP of Clinical Development, Kendle International Inc., Cincinnati; Kendle is a global provider of clinical development, regulatory/validation consulting, and medical communications services to the pharmaceutical and biotechnology industries. For more information, visit kendle.com.
Stedman Stevens. President and Chief Operating Officer, Pharmaceutical Research Plus Inc., Severna Park, Md.; PRP was founded in 1994 to introduce a new method to accelerate patient recruitment for pharmaceutical clinical trials. For more information, visit prpi.com.
Brian Stone, M.D. Chief Medical Officer, The Black Health Network, New York; The Black Health Network provides value-added clinical-research services to pharmaceutical and biotechnology companies seeking minority investigators, site initiation, and data collection on an electronic data capture platform, and in-depth physician-driven health content geared toward the African-American community and a minority physician referral system for virtually every medical specialty. For more information, visit blackhealthnetwork.net.
Sheila Thorne. President, Multicultural Healthcare Marketing Group LLC, Teaneck, N.J.;Multicultural Healthcare Marketing Group employs seasoned, in-language, in-culture professionals with an in-depth understanding of the pharmaceutical and healthcare industry and extensive experience in multicultural marketing. For more information, call 973-331-8322.                Ronald G. Walls, M.D. Medical Affairs Director, clinical development and medical affairs, cardiovascular and urologic
diseases, GlaxoSmithKline, Research Triangle Park, N.C.; GSK, with U.S. headquarters in Philadelphia, is one of the world’s leading research-based pharmaceutical and healthcare companies. For more information, visit gsk.com.

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