Identifying Social Determinants in Clinical Trial Screening
Social determinants of health (SDoH) are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes. Collectively, they contribute significantly “to the social patterning of health, disease, and illness,” according to the CDC.
Examples of these social determinants include safe and affordable housing, access to education, public safety, availability of healthy foods, local emergency/health services, and environments free of life-threatening toxins. A study showed that nationally, patients faced an average of 7.2 out of 22 social risks. The most common SDoH risks among all three cohorts in the study were limited English proficiency, less than a high school education, lack of insurance, experiencing high to medium-high stress, and unemployment.
If SDoHs have an impact on clinical outcomes, then it stands to reason that they may also have an impact on clinical trial outcomes. A study by Yale University in 2019 demonstrated this phenomenon. Their study, published in the Journal of the American Heart Association, compared outcomes in an interventional study (ALLHAT) comparing medications for hypertension. Their results showed that patients who received their care in low-income areas had vastly different outcomes than patients in higher income areas. “Despite standardized treatment protocols, ALLHAT participants in the lowest‐income sites experienced poorer blood pressure control and worse outcomes for some adverse cardiovascular events, emphasizing the importance of measuring and addressing socioeconomic context,” according to the authors.
Despite these findings, and general acceptance of the role of social determinants, these factors are rarely reported in clinical trial results, according to a JAMA study published in May of this year.
Clinicians do not agree on whether to screen for social determinants. They offer various reasons for this resistance. A survey conducted by the Robert Wood Johnson Foundation found that four out of five physicians do not feel confident in their capacity to meet their patients’ social needs, and they believe this impedes their ability to provide quality care. Physicians do not have the time or sufficient staff support to address patients’ social needs, according to the study.
While the FDA has offered guidance to sponsors regarding the collection of ethnicity data in clinical trials, there is no specific guidance on collecting information about SDoHs.
The recently announced CURES 2.0 Act, which includes provisions for creating a new research agency, Advanced Research Projects Agency for Health, or ARPA-H, also generally calls for increased diversity in clinical trials and the collection of so-called “real world data.” Social and economic conditions can negatively impact willingness and ability to participate in research. Recognition and understanding of SDoHs may help address and overcome barriers to minority participation in research. But the proposed law does not specifically address the collection or analysis of SDoHs as part of clinical trial screening.
For clinician-investigators interested in including this information about study participants, a variety of screening tools are available. The American Academy of Family Physicians, American Academy of Pediatrics, and the National Association of Community Health Centers all offer these instruments online. These may require additional training for research staff or adjustments to workflow in the screening process. An article published in 2020 suggested certain data points may act as surrogates for collected detailed information about SDOHs. The American Association of Family Physicians developed a checklist for primary care practices to prepare for screening SDOHs.
There is a national movement to understand the barriers to diversity in clinical trials, and the impact of social determinants in health outcomes. While there are no specific requirements to include this data in the screening process, clinician-investigators can include this in their protocols to gain a clearer understanding of these factors in their trial endpoints.