Social Determinants of Health Should Be an Integral Component of Cancer Clinical Trials

Periods of crisis often underscore the best and worst in individuals, society, and institutions. The COVID-19 pandemic is no exception, and it has highlighted the marvels of rapid technologic advances while spotlighting the social issues that have been evident for decades but ignored and poorly addressed in many cases. Health care delivery in the United States has been fractured and is not immune to larger social issues, including disparities, inequality, and bias.

Social determinants of health (SDOH) are the factors encompassing our past, present, and future lives. The World Health Organization defines SDOH as the “conditions [into] which people are born, [and] grow, live, work, and age [in]” and “the fundamental drivers of these conditions.”¹ SDOH, including lower socioeconomic zip codes and areas of deprivation, are linked to cancer outcomes such as lower cancer screening rates, later stage at diagnosis, higher rehospitalization rates, and higher mortality.^2-6 A large SWOG Cancer Research Network cohort analysis of pooled data demonstrated that only patients with private insurance had an overall survival and a progression-free survival benefit from experimental therapies compared with those with Medicaid or no insurance.⁷ This calls into question the link of insurance status as a surrogate for other SDOH such as overall socioeconomic status. As the cost of cancer treatment rises, the impact of SDOH may become even more relevant.⁸

Clinical trials are the cornerstone to advancing cancer care but only approximately 8% of patients participate in a clinical trial. Despite innumerable efforts to improve accrual in cancer clinical trials, low patient participation has persisted, especially among important subgroups including Black and American Indian/Alaska Native populations and those who are 70 years or older.⁹ The FDA’s recently reported results from a 5-year plan to improve diversity in and transparency of clinical trials for newly approved drugs, including oncology drugs, did not increase the participation of Black individuals in trials.¹⁰ Financial barriers to clinical trial participation, including insurance coverage and logistical or transportation concerns, have been cited as contributing elements to the lack of diversity in clinical trials.¹¹

Most patients with cancer are treated in a community setting and in a recent survey, 165 medical oncologists at Cardinal Health Oncology Provider Extended Network reported viewpoints on SDOH that are intended to inform potential solutions to offset the negative impact on such patients.¹² The overwhelming majority of oncologists recognized that SDOH affected the likelihood of patients receiving optimal health outcomes, including financial security (83%), access to transportation (58%), patient health literacy (53%), social isolation (43%), housing security (18%), addiction (12%), and food security (7%). Physicians also stated that assistance programs addressing the cost of medicine and transportation to a medical facility would be of great help to their patients. Despite this recognition, the respondents acknowledged there was insufficient time to address these important SDOH and were constrained by the lack of accessibility of assistance programs. In addition, oncologists believed that patients’ social needs should be addressed by a composite of organizations including government, hospitals and cancer centers, nonprofit groups, insurance payers, and pharmaceutical manufacturers.

Recognizing and addressing patient values and perspectives, experiences, and needs are essential components of any comprehensive cancer care program. Implementation of available supportive care services remains a significant challenge for many cancer centers. Innovative strategies are needed to identify and subsequently intervene for patients who are at risk of poor outcomes. One example of a potential assistance tool is available through the Epic electronic health record (EHR), which has created SDOH domains that focus on transportation needs, financial resource strain, tobacco use, stress, intimate partner violence, housing stability, alcohol use, food instability, physical activity, social connections, and depression. These domains not only enhance the recognition of factors indicative of SDOH and encourage patient identification of these areas of concern but also provide a vehicle for automatic referral to supportive care services. In addition, with the increasing necessity to incorporate SDOH in clinical trial design, having a mechanism to routinely collect discrete SDOH data in an accessible and useable format will enhance the ability to systematically report these data for clinical trials and other databases for outcome analyses.

Improving equity has been identified as a priority for several high-impact organizations nationally. The American Cancer Society, in their 2020 blueprint for practice, research, and policy, provided a construct to eliminate cancer-related disparities with recommendations that address structural inequities, institutional environments, living environments, risk factors, and the spectrum of cancer comorbidities and mortality.⁶ The American Medical Association has approved a 2020 policy that replaces race with genetic ancestry or zip code to capture the contribution of biologic differences and neighborhood deprivation on health disparities traditionally attributed to race.^13,14 In 2017, the American Society of Clinical Oncology (ASCO) Health Disparities Committee outlined recommendations to address financial barriers to cancer clinical trials participation. Their recommendations include the following: (1) Medicaid coverage of routine care costs of clinical trials; (2) provision of patient out-of-pocket costs and mechanisms to support patient financial and health literacy; (3) the offer of financial navigation and counseling to patients by research sites; (4) minimization of incremental costs by design trials; and (5) removal of impediments to ethically appropriate financial compensation for trial-related out-of-pocket costs.¹⁵

Most recently, programs have evolved to promote cancer research in local communities with an emphasis on equity. Examples include the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute16 and the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials (www.asco.org). There is heightened awareness that innumerable past approaches to increase clinical trial participation have produced no significant boost in the percentage of individuals enrolled, resulting in delayed advancements in prevention, screening, diagnostics, and treatment. The relative paucity of diversity in most trials confounds a trial’s key findings and limits the interpretation of results to broader populations. The hope is that by integrating SDOH as a component of routine comprehensive cancer care delivery, patients will receive the services they need and deserve and some barriers to clinical trial participation will be removed for our most vulnerable patients.

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