5 - Integrating Social Determinants of Health (SDOH) into Clinical Trials: Feasibility Assessment, and Early Results

Background:  Clinical trials overlook the socioeconomic factors that affect health outcomes of patients. Industry-sponsored trials offer an opportunity to collect and assess SDOH data in a way that is neither burdensome to patients nor resource-intensive for sponsors. This can help elucidate patterns in SDOH and how they relate to health outcomes.

Methods:  We developed an SDOH questionnaire to capture patient and area-level data such as education, income, employment status, marital status, insurance status, and 5 digit zip code of home residence. The 5-digit zip code was linked to the Social Vulnerability Index which is a published measure using 16 US census variables, providing an insight on communities that are vulnerable. The questionnaire was deployed in three clinical trials; data from one trial is presented here.

Conclusion:  This study outlines the process of integrating SDOH data collection into clinical trials. Additionally, it presents an initial assessment of the collected SDOH data and offer insights into their potential utility in clinical practice. The study found that collection of SDOH is feasible and aligns with efforts by industry and the FDA to increase diversity in clinical trials. Collecting SDOH alongside clinical trials is also crucial and will advance our understanding of the socioeconomic factors that contribute to patient experiences and healthcare outcomes of the investigated interventions.

Limitations: This study has limited sample size, with data analyzed for 100 patients. Collecting five digit zip code provides insight into the patient's physical community, but collecting census block data would elucidate more specific patterns. However, due to privacy concerns, census block data cannot be collected. Zip code is the most granular data point that can be collected to understand SDOH patterns while not putting patients' privacy at risk.

Discussion:  Data from 100 patients in the evERA trial were analyzed. The complete response for all variables was at 100%, except for income (95%) and 5-digit zip code (98%). Of those who responded, the majority of patients were married or living with domestic partners (58%), 41% of patients were full-time employees and 45% had private or commercial insurance. Almost ⅓ of patients (32%) reported an income exceeding $100,000, while a smaller proportion of patients had a high school level education or less (27%). The participants in the evERA trial reside in areas characterized by very high vulnerability.