Currently more than one-third of the U.S. population is of a minority population. Between 2000 and 2008, the U.S. Census Bureau estimates that U.S. minority population has reached 104.6 million people, or 34% of the nation's total population, up from 31% in 2000. Even more telling of the changes to come, 44% of the children under the age of 18 are born to minority families, and nearly 48% of the children under age 5 are from minority families. These data are important in the setting of less than 5% of all adults diagnosed with cancer or other chronic diseases are enrolled in clinical trials and of that only 10% are minorities. These challenging data provide a backdrop for increasing the cost of health care due to persistent disparities in treatment outcomes and access to health care through therapeutic and population-based trials. In light of our current population dynamic, failing to increase minority participation in clinical trials is not an option. Failing to do so perpetuates two health care systems through producing clinical trial results that often neglects the specific needs regularly identified from these trials to effectively treat minority populations - failure to increase minority participation misses the opportunity to provide effective, detailed, and often improved care via clinical trials. A focus on recruitment of minorities into clinical trials also provides a novel mechanism to engage the part of our nation at the greatest medical risk, those on the fringe of the healthcare safety net and for whom data is persistently limited and/or missing in the areas of chronic diseases and cancer. Our proposal, Enhancing Minority Participation in Clinical Trials (EMPaCT), seeks to establish a national network through two internationally recognized leaders at the University of Minnesota and the University of Alabama at Birmingham in the areas of health disparities and cancer care, both actively involved leaders in their NCI-designated comprehensive cancer centers and NCMHD centers of excellence, to build regional consortia through 5 U.S. Regions and regional institution leaders. Each of these Regions will include 4-7 academic institutions with NCI-designated cancer centers and NCMHD-funded health disparities programs and target minority serving institutions with health disparity programs. This program seeks to increase minority recruitment and retention into clinical trials through the following Specific Aims: 1. Develop a regional consortia and network of individual institutions and centers to enhance minority participation in clinical trials;2. Develop community-based participatory research and education programs to combat the underlying mistrust of the medical research community;3. Enable EMPaCT participating institutions to enhance minority participation in clinical trials by implementing models shown to more successfully link investigators with their target communities;4. Provide the environment for conducting clinical research for minority-related diseases. Enhancing Minority Participation in Clinical Trials (EMPaCT) is a national network and regional consortia for the recruitment and retention of underrepresented minorities into clinical trials. The research strategy will establish coordinated underrepresented minority patient recruitment and retention infrastructure within each participating cancer center based on an assessment of each center's existing resources and needs and to encompass a patient recruitment model and/or a patient navigation model, integrating the expertise of the NCI- funded cancer center and the NCMHD-funded center of excellence at the local institution. The regional consortia system and its lead institutions will provide points of development and expertise enhancing minority participation in clinical trials through education and infrastructure. The program will be supported through an online national database of cancer clinical trials, a web-based education module for health care providers, and a communication platform for supporting the national network. The two lead institutions (UMN and UAB) will coordinate the evaluation of all EMPaCT objectives and activities.

Public Health Relevance

Enhancing Minority Participation in Clinical Trials (EMPaCT) is a national network and regional consortia for the recruitment and retention of underrepresented minorities into clinical trials. The research strategy will establish coordinated underrepresented minority patient recruitment and retention infrastructure within each participating cancer center based on an assessment of each center's existing resources and needs and to encompass a patient recruitment model and/or a patient navigation model, integrating the expertise of the NCI- funded cancer center and the NCMHD-funded center of excellence at the local institution. The regional consortia system and its lead institutions will provide points of development and expertise enhancing minority participation in clinical trials through education and infrastructure. The program will be supported through an online national database of cancer clinical trials, a web-based education module for health care providers, and a communication platform for supporting the national network. The two lead institutions (UMN and UAB) will coordinate the evaluation of all EMPaCT objectives and activities.

Agency
National Institute of Health (NIH)
Institute
National Institute on Minority Health and Health Disparities (NIMHD)
Type
High Impact Research and Research Infrastructure Programs (RC2)
Project #
1RC2MD004797-01
Application #
7852572
Study Section
Special Emphasis Panel (ZMD1-PA (R5))
Program Officer
Goodwin, Paula
Project Start
2009-09-27
Project End
2011-06-30
Budget Start
2009-09-27
Budget End
2010-06-30
Support Year
1
Fiscal Year
2009
Total Cost
$2,954,832
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Surgery
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Simoni, Zachary R; Martin, Michelle; Wenzel, Jennifer A et al. (2016) A Qualitative Study of Motivations for Minority Recruitment in Cancer Clinical Trials Across Five NCI-Designated Cancer Centers. J Racial Ethn Health Disparities :
Wenzel, Jennifer A; Mbah, Olive; Xu, Jiayun et al. (2015) A Model of Cancer Clinical Trial Decision-making Informed by African-American Cancer Patients. J Racial Ethn Health Disparities 2:192-9
Ghebre, Rahel G; Jones, Lovell A; Wenzel, Jennifer A et al. (2014) State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Cancer 120 Suppl 7:1122-30
Vickers, Selwyn M; Fouad, Mona N (2014) An overview of EMPaCT and fundamental issues affecting minority participation in cancer clinical trials: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual. Cancer 120 Suppl 7:1087-90
Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C et al. (2014) Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT). Cancer 120 Suppl 7:1097-105
Hawk, Ernest T; Habermann, Elizabeth B; Ford, Jean G et al. (2014) Five National Cancer Institute-designated cancer centers' data collection on racial/ethnic minority participation in therapeutic trials: a current view and opportunities for improvement. Cancer 120 Suppl 7:1113-21
Groth, Shawn S; Al-Refaie, Waddah B; Zhong, Wei et al. (2013) Effect of insurance status on the surgical treatment of early-stage non-small cell lung cancer. Ann Thorac Surg 95:1221-6
Markin, Abraham; Habermann, Elizabeth B; Zhu, Yanrong et al. (2013) Cancer surgery among American Indians. JAMA Surg 148:277-84; discussion 284
Chow, Christopher J; Habermann, Elizabeth B; Abraham, Anasooya et al. (2013) Does enrollment in cancer trials improve survival? J Am Coll Surg 216:774-80; discussion 780-1
Markin, Abraham; Habermann, Elizabeth B; Chow, Christopher J et al. (2012) Rurality and cancer surgery in the United States. Am J Surg 204:569-73

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