Enhancing Minority Participation In Clinical Trials Research Articles

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Diversity and Inclusion in Pancreatic Cancer Clinical Trials

Abstract IA40: Maximizing the benefits of precision medicine for cancer disparities

Abstract Disparities, defined as differences that are unnecessary and avoidable, exist in cancer incidence, mortality, and survival. They occur by race/ethnicity, socioeconomic status, geography (rural versus urban), and other factors. Although cancer deaths for all types of cancer decreased for both African-Americans and whites in the United States between 1999 and 2011, for example, African-American males and females had both higher cancer incidence and cancer mortality than white males and females and showed less marked improvement over that time period. Warnecke and colleagues published a multi-level framework of the determinants of cancer disparities that included three basic levels, namely distal, intermediate, and proximal.1 Distal determinants include population-level social conditions such as variation in rates of disease or poverty. Their roots are embedded in shared social norms or social practices and socioeconomic disadvantage. Intermediate determinants include the immediate social and physical contexts and social relationships in which distal effects are experienced, such as neighborhoods. Proximal determinants include biological and genetic factors and individual-level factors like health behavior. The sequencing of the human genome and increased understanding of its function have allowed the identification of genetic variants that lead to common diseases like cancer. Yet, awareness is growing, too, that genetic variants alone cannot account for cancer expression and outcomes. Consistent with the Warnecke et al. framework, it seems to be the case that social, environmental, and behavioral factors interact with genetic predisposition to produce disease, and that differential exposures and behaviors across populations and subpopulations might help to explain cancer disparities. Both the genetic variants and the exposures and behaviors must be present to produce cancers. The Precision Medicine Initiative (PMI), announced by President Obama on January 30, 2015 seeks to advance our understanding of genetic variations within diseases and develop treatments for them, beginning with cancer. President Obama requested $215 million in the next fiscal year to collect genetic data and data from electronic medical records, lab test results, and information about diet, tobacco use, lifestyle, and environment on 1,000,000 Americans. In this presentation, we argue that while the PMI has the potential to reduce cancer disparities: (1) preventing cancer and reducing death rates for everyone in the population requires collecting and analyzing consistent, accurate, reliable, and sufficiently detailed data that represent all segments of the population and that (2) developing risk assessments and interventions that are effective for everyone requires evidence on the distribution and impact of causes across subpopulations. Collecting and analyzing data that represents all segments of the population poses significant challenges essential for the PMI to contribute to decreasing disparities in cancer and other common diseases. Minority groups historically have had low participation in research, such as in clinical research trials. The 1993 NIH Revitalization Act (http://orwh.od.nih.gov/about/pdf/NIH-Revitalization-Act-1993.pdf) established a mandate that funded research would be based on valid analysis of whether the variables being studied in the trial affect minority groups. Yet a 2014 review found that only 20% of randomized controlled studies in a major cancer journal reported analyzing results by race/ethnicity.2 Likewise, a survey of its members and the general public by the American Association for the Advancement of Science (AAAS) found that while 92% of AAAS scientists considered US scientific achievement to be the best in the world or above average, only 54% of the public endorsed this ranking.3 The presentation will conclude with two recommendations for improving the PMI's role in eliminating cancer and other disparities. First, make the effort to recruit a cohort that reflects the US population in terms of race/ethnicity, socioeconomic status, and geography. Second, do not recruit entirely from clinic populations or rely entirely on electronic medical records for social data, because this will miss those most without consistent health care, a group for whom disparities are rife. In addition, for Precision Medicine practice to contribute to the elimination of disparities, it will be important that: (1) the cost of genetic testing is covered under Medicaid, other public insurance, and less generous marketplace insurance plans; (2) the collection of social variables be systematized so that they capture the lives of minority groups; and (3) the capacity of genetic counseling is increased and that counseling services are available to all who have genetic testing.

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

This supplement provides an overview of the interventional efforts as well as scientific data regarding the undertaking by the EMPaCT consortium to document the scope of the problem and the results from multiple methods of interventions for increasing minority accrual in clinical trials.

Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

The opinions or views expressed in this supplement are those of the authors and do not necessarily reflect the opinions or recommendations of the journal editors, the American Cancer Society, John Wiley & Sons, Inc., or the National Institute on Minority Health and Health Disparities. The articles in this supplement were prepared as part of the National Institute on Minority Health and Health Disparities-funded grants EMPaCT I, RC2MD00497 and EMPaCT II, U24MD006970, and by a grant from the National Cancer Institute, U54CA153499. We are also grateful for the extensive assistance provided by Ms. Tina Fung, MPH, Program Coordinator for The National Center for Reducing Asian American Cancer Health Disparities.

Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

BACKGROUNDThe National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH‐funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer burden for minorities will increase.METHODSFor this review article, the authors counted the frequency with which minorities were the primary focus of National Cancer Institute‐sponsored clinical trials, examined citations from the PubMed database focusing on the search terms “NIH Revitalization Act of 1993” and “enhancing minority accrual to cancer clinical trials,” and supplemented the review with their expertise in NIH‐funded research related to minority accrual in cancer clinical trials.RESULTSThe reporting and analyses of data based on minorities in clinical trials remain inadequate. Less than 2% of the National Cancer Institute's clinical trials focus on any racial/minority population as their primary emphasis. The current review of the literature indicated that the percentage of authors who reported their study sample by race/ethnicity ranged from 1.5% to 58%, and only 20% of the randomized controlled studies published in a high‐impact oncology journal reported analyzing results by race/ethnicity. Proportionately greater population increases in minorities, accompanied by their persistent and disproportionate cancer burden, reinforce the need for their greater representation in clinical trials.CONCLUSIONSRenewing the emphasis for minority participation in clinical trials is warranted. Policy changes are recommended. Cancer 2014;120(7 suppl):1091–6. © 2014 American Cancer Society.

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)

BACKGROUNDThe study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment.METHODSIn total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment.RESULTSThe perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities.CONCLUSIONSMultilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. Cancer 2014;120(7 suppl):1097–105. © 2014 American Cancer Society.