A consortium of 5 institutions is working to increase participation of racial and ethnic minorities in clinical trials of cancer therapies, under a $5.1-million cooperative agreement from the National Institute of Minority Health and Health Disparities.
Centers aim to boost enrollment in cancer clinical trials from about 9% to 14% over 5 years
Although racial and ethnic minorities make up one third of the population in the United States, only about 10% of adults who participate in clinical trials represent minorities—African Americans and blacks, Hispanics, Native Americans, Alaska Natives, Asian Americans, Native Hawaiians, and other Pacific Islanders. That can make it difficult to accurately assess the safety and effectiveness of investigational medications and medical devices for these groups and across the population as a whole.
To better understand and address barriers that limit the participation of minorities in cancer therapeutic trials, the National Institute of Minority Health and Health Disparities (NIMHD) recently awarded a 5-year, $5.1-million cooperative agreement to Enhancing Minority Participation in Clinical Trials (EMPaCT). EMPaCT is a consortium of 5 National Cancer Institute–designated cancer centers with NIMHD disparities research programs. The institutions, spread around the country and focusing on different minority groups, include:
the University of Minnesota Medical School in Minneapolis, lead institution for EMPaCT
the University of California (UC), Davis, Comprehensive Cancer Center in Sacramento
the University of Alabama at Birmingham (UAB) Comprehensive Cancer Center
the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore
the University of Texas MD Anderson Cancer Center in Houston.
The funding follows on the heels of an earlier $3.8-million start-up grant for EMPaCT, which ends in June. That money, awarded in 2009 as part of the American Recovery and Reinvestment Act, was used to assess barriers to recruitment and retention of racial and ethnic minorities in clinical trials—and determine best practices to boost enrollment.
The reasons many racial and ethnic minorities don't participate in clinical trials vary, says Moon Chen Jr, PhD, MPH, head of the UC Davis EMPaCT team and associate director for cancer control at the institution's cancer center. Among them are cultural and religious factors, lack of awareness of clinical trials, historical mistrust of the medical system, and costs associated with participating in a trial, such as transportation.
Researchers aim to increase enrollment of racial and ethnic minorities in new and existing cancer clinical trials at EMPaCT medical centers by 5 percentage points—from about 9% to 14%—over the next 5 years. Although that accomplishment would only partly close the gap in minority participation, “a large number of socioeconomic factors are outside of our control,” explains the University of Minnesota's Selwyn Vickers, MD, EMPaCT's principal investigator. “Obviously, it's our desire to enroll even more participants, but this is a credible and achievable starting goal.”
To reach the goal, the researchers will create Web-based training and educational materials for investigators, research staff, and referring physicians, with each of the institutions developing a module. Data collected as part of their earlier research, which are still being compiled, will help EMPaCT investigators finalize a list of topics to cover, notes Vickers. For example, UC Davis will likely focus on cultural competence, to help those involved in research better understand, communicate with, and effectively interact with people from different cultural backgrounds.
“Developing a Web portal seemed like the best way to roll out the curriculum because disparate sites need to work together and because we need a broad, national approach” to boosting minority recruitment in cancer clinical trials, Vickers explains.
Based on their earlier findings, each institution will also establish a clinical trial support system, with a patient navigator to answer questions posed by patients considering a clinical trial and to offer ongoing support after enrollment. Patient accrual in trials will be monitored by a standardized, real-time tracking system, which will also be evaluated.
Increasing racial and ethnic diversity in clinical trial cohorts is a requirement that needs to be met, says Mona Fouad, MD, MPH, director of the UAB Minority Health and Health Disparities Research Center and EMPaCT co-principal investigator. “By failing to find ways to increase minority participation in clinical trials,” she says, “we miss the opportunity to provide effective, detailed, and often improved care for everyone.”