**4.2 Eliminating disparities and enhancing diversity in clinical trials**

The improvement in health status in a community, region or country can be measured in many ways. Sir Michael Marmot, WHO Chair of the Commission on Social Determinants of Health, posits that the health care system accounts for about 20% of this.(Wilkinson and Marmot 2003) Improved health status is greatly impacted through social policy such as controlling access to tobacco or designing communities that provide conditions that support walking rather than dependence on mass transit. Such environmental interventions do not eliminate the need or benefit of required individual application or adoption of preventive behaviors such as smoking cessation, increased exercise, better dietary choices, or breast feeding.

However, when someone is diagnosed with a life threatening disease like cancer, it is no longer a question of how to prevent an occurrence; it is time to provide access to the best quality of care. For this, the process of informed decision making begins with their clinician, and what do they offer? What are they required to offer? Unfortunately, there is less participation in clinical trials and often the clinician's failure to provide information as a part of their care options is at the root of the problem. Yet there are many others in the cancer workforce that have an equally important role in guiding patients, supporting their decision making process, and helping them as participants if they choose to enter a clinical trial.

Clinical trials are a critical resource for developing new lifesaving drugs as well as better prevention, diagnostic, and treatment methods. However, numerous demographic groups are underrepresented in cancer clinical trials. These include racial and ethnic minorities, the elderly, women, children and adolescents, low income and uninsured individuals, rural residents, and individuals with disabilities.

There is no single reason why the evidence consistently demonstrates widespread disparities in clinical trial participation. Rather, multiple factors coalesce to produce a system that features such disparities. Accordingly, the Eliminating Disparities in Clinical Trials (EDICT) Project sought to model an approach that would not merely address individual contributing variables, but would instead analyze the problem and proposed solutions via a systematic, multi-level approach.(ICC 2009)

Each of the more than 300 EDICT participants represented one or more of the many stakeholders who encountered the multiple factors that produce underrepresentation in clinical trials. For example, concerns of scientific validity suggest that protocol design include, from the outset, recognition of patterns of disease burden and, where appropriate, reflect those patterns in recruitment and retention strategies. In addition, members of underrepresented populations consistently report mistrust of medical and research professionals, in contrast to local community healthcare workers, who are rarely involved with clinical research. Finally, the mistaken belief that appropriate representation in clinical trials requires larger expenditures in conducting the trial(s) justifies the unwarranted assumption that ameliorating disparities in clinical trials is cost-ineffective.

These examples demonstrate how the factors contributing to the problem of disparities in clinical trials operate at different levels, across different sectors, and involve different stakeholders. The primary initial result of the EDICT Project is the 33 Policy Recommendations. There are both data and theory strongly suggesting that if relevant

The improvement in health status in a community, region or country can be measured in many ways. Sir Michael Marmot, WHO Chair of the Commission on Social Determinants of Health, posits that the health care system accounts for about 20% of this.(Wilkinson and Marmot 2003) Improved health status is greatly impacted through social policy such as controlling access to tobacco or designing communities that provide conditions that support walking rather than dependence on mass transit. Such environmental interventions do not eliminate the need or benefit of required individual application or adoption of preventive behaviors such as smoking cessation, increased exercise, better

However, when someone is diagnosed with a life threatening disease like cancer, it is no longer a question of how to prevent an occurrence; it is time to provide access to the best quality of care. For this, the process of informed decision making begins with their clinician, and what do they offer? What are they required to offer? Unfortunately, there is less participation in clinical trials and often the clinician's failure to provide information as a part of their care options is at the root of the problem. Yet there are many others in the cancer workforce that have an equally important role in guiding patients, supporting their decision making process, and helping them as participants if they choose to enter a

Clinical trials are a critical resource for developing new lifesaving drugs as well as better prevention, diagnostic, and treatment methods. However, numerous demographic groups are underrepresented in cancer clinical trials. These include racial and ethnic minorities, the elderly, women, children and adolescents, low income and uninsured individuals, rural

There is no single reason why the evidence consistently demonstrates widespread disparities in clinical trial participation. Rather, multiple factors coalesce to produce a system that features such disparities. Accordingly, the Eliminating Disparities in Clinical Trials (EDICT) Project sought to model an approach that would not merely address individual contributing variables, but would instead analyze the problem and proposed

Each of the more than 300 EDICT participants represented one or more of the many stakeholders who encountered the multiple factors that produce underrepresentation in clinical trials. For example, concerns of scientific validity suggest that protocol design include, from the outset, recognition of patterns of disease burden and, where appropriate, reflect those patterns in recruitment and retention strategies. In addition, members of underrepresented populations consistently report mistrust of medical and research professionals, in contrast to local community healthcare workers, who are rarely involved with clinical research. Finally, the mistaken belief that appropriate representation in clinical trials requires larger expenditures in conducting the trial(s) justifies the unwarranted

These examples demonstrate how the factors contributing to the problem of disparities in clinical trials operate at different levels, across different sectors, and involve different stakeholders. The primary initial result of the EDICT Project is the 33 Policy Recommendations. There are both data and theory strongly suggesting that if relevant

**4.2 Eliminating disparities and enhancing diversity in clinical trials** 

dietary choices, or breast feeding.

residents, and individuals with disabilities.

solutions via a systematic, multi-level approach.(ICC 2009)

assumption that ameliorating disparities in clinical trials is cost-ineffective.

clinical trial.

stakeholders implemented even a minority of the recommendations, disparities in clinical trials could be substantially reduced. Because of this complexity, eliminating disparities in clinical trials requires a multi-level systems approach and certainly one that requires the creation of a fully engaged and competent workforce. (Wilkinson and Marmot 2003; ICC 2009)

The EDICT Credo can serve as a framework for training and sustaining a workforce that ensures the appropriate inclusion of under-represented populations are ameliorated in the future. The following beliefs guide the work of the EDICT Project:


Creating such a workforce will require attention to barriers related to researchers, referring physicians, and the recruitment process itself. For example, racial/ethnic minorities are underrepresented among researchers. Community physicians are often unaware of clinical trial opportunities and experience excessive administrative or financial burden related to clinical trials. Additional barriers include lack of institutional interest, infrastructure, staff time, sufficiently skilled research coordinators, and training in culturally competent communication skills related to clinical trial recruitment.

A competent workforce should be capable of understanding frequent patient barriers to recruitment that are exacerbated for underrepresented groups. These barriers include poor understanding of the research and its related risk; transportation difficulties and caregiver availability; participant fatigue and inconvenience; general lack of awareness that clinical trials are an option; mistrust due to previous unethical research experiences; cultural, linguistic, and literacy issues; inadequate paid work leave, childcare, or insurance coverage; misidentification of race/ethnicity; and relocations, extended visits, or return to countries of origin.

While helping potential participants to "navigate" their way into, through, and after the clinical trial process is critical to improving inclusion of these groups in cancer research. The task is complicated by the fact that there are multiple professionals and paraprofessionals involved in recruitment and retention of participants in clinical trials at different points of contact along the continuum of cancer care. These include, but are not limited to, clinical researchers, research administrators, community health workers and promotoras,*,* nurses, patient navigators, physicians who refer patients, physician assistants, and social workers to name a few.

The Department of Health and Human Services (DHHS) Office of Minority Health (OMH) developed National Standards for Culturally and Linguistically Appropriate Services (CLAS) in 2000. The CLAS-And Clinical Trials (CLAS-ACT) Project helps to assess how well CLAS Standards are implemented in a single clinical trial or study as well as across multiple trials in an organization. CLAS-ACT materials may also be used to train research staff and administrators about CLAS standards. These standards are a straightforward method to support taking one significant step in providing a cancer workforce in general but in

Creating a Sustainable Cancer Workforce: Focus on Disparities and Cultural Competence 411

Nearly all of the professional disciplines that play a role in the delivery of comprehensive cancer services are experiencing a shortage including physicians, nurses, social workers, pharmacists, public health workers, researchers, technologists, and cancer registrars. The rising incidence of cancer, an aging population, and an increased rate of cancer survivorship all predict an increased demand for health services. These trends threaten our ability to provide timely and comprehensive cancer care. Many cancer-focused organizations are investing in efforts to expand the number of cancer specialists in anticipation of a worsening

Complementing other national efforts focused on the recruitment and retention of oncology health professionals, C-Change pursued the Cancer Core Competency Initiative to develop standards and tools for strengthening the cancer knowledge and skills of non-oncology health professionals, including generalist and other non-oncology specialists. Defining the core competencies needed by all members of the health workforce represents one important approach toward expanding the cancer workforce (Figure 2). A multi-disciplinary panel of national leaders and experts developed competency standards spanning the continuum of cancer care, basic cancer science, and communication and collaboration. Implementation tools included a logic model and curriculum validation template.(C-Change 2008; Smith,

**Continuum of Care** Prevention | Early Detection | Treatment | Survivorship | Palliative Care **Basic Cancer Science** Etiology | Epidemiology | Clinical Trials | Cancer Surveillance **Communications & Collaboration** Inter-disciplinary Care | Psychosocial Communication Cross-Cultural Communication

In an effort to test this approach, a grant program invited applicants from any academic, healthcare, cancer coalition, or voluntary/advocacy organization to apply the standards and tools to address a specific need in the professionals and, ultimately, the patients that they serve. Four grant-funded sites implemented the C-Change Cancer Core Competency Program in their organization by utilizing this rigorous set of competency standards, curriculum design tools, and evaluation methods to create their own programs. Each of the grant sites focused on a unique combination of a cancer topic, discipline,

education/experience level, and practice setting.(C-Change 2008)

**5. Revitalization of cancer care: cancer competencies framework** 

**5.1 Building a cultural bridge through a competency-based approach** 

cancer workforce crisis.

Tyus et al. 2009)

Fig. 2. Scope of competency standards.

particular for those involved in clinical research they can be instrumental in bringing the research experience into a comparable position with overall access to health care services in general.

"Imagine that you possess an indicator for a disease or illness that has nothing to do with your body. It is not a genetic predisposition to acquire cancer or a vice that raises the probability of contracting some dread disease, though estimates of its health risks have placed it on par with having diabetes. It has nothing to do with the environmental pollutants you are exposed to or whether you can afford health care. It is not a physical susceptibility that renders you more easily reachable by the clutches of pathology. No, this indicator of health hinges on certain learned abilities and skills, and it is a barrier to health that is totally within the health field's power and resources to lift. The condition hinted at above is the inability to speak English proficiently in the United States."(Bustillos 2009)

Correcting for this will not be easy. Little data exists on issues such as this in the clinical research enterprise. What will be important is the ability to recognize that it will be both a combination of policy and programs that culminate in a competent corps of health care workers. Indeed as an evidence base is developed we must recall that those currently in the cancer workforce can make a significant step by striving for cultural competence. The nature of funding and conducting randomized clinical trial research is changing to reflect the evolution of the science base, the need to increase diversity among study participants, to establish trust among certain communities by acknowledging the need for social justice and health equity, and of course the globalization of drug development and emerging markets. In response, there are significant efforts underway to address the barriers to participation in clinical trials, which remain low.(Wilkinson and Marmot 2003)

The National Cancer Institute recently conducted research with oncology professionals that identified unmet accrual needs. As a result they have developed a comprehensive platform for accrual resources, AccrualNet.(NCI 2011) Their methodology used a variety of techniques including literature and resource searches to identify the content for the site. Certainly, as noted throughout EDICT's recommendations, designing interventions to support a broader the workforce must meet different barriers AccrualNet represents a unique, centralized comprehensive-solution platform to systematically capture accrual knowledge for all stages of a clinical trial. It is designed to foster a community of practice by encouraging users to share additional strategies, resources, and ideas.(NCI 2011)

For those who recognize the importance of clinical trials there is an opportunity to educate, encourage, and inform others. It is important to learn how to intervene with members of the cancer workforce who today have the ability to increase awareness about clinical trials and provide patients the opportunity to consider participation in a clinical trial. We need to make this part of our education and training of future workforce, if not, we are likely to have medicine's role in improving the quality of life diminish rather than flourish.

The lesson of EDICT is that there are many things that need our attention if we are truly to overcome the barriers to increasing participation in clinical trials. However, it is clear that if those (our cancer workforce) who can do something will, ultimately we will succeed.
