Abstract A133: Mapping the legal estrangement theory onto known barriers in recruiting diverse participants to clinical trials
Authors: Abraham Cilgy M. , O'Malley Denalee M. 
Published: December 2023

Abstract
Lack of diversity in clinical trials research has significant health consequences because medications and treatments have varying effects on people based on their demographic, socio-economic, and geographic characteristics. This study uniquely adopts the legal estrangement theory to explain the causes for limited diversity in federally funded clinical trials and offers multi-level strategies that researchers, institutions, the US Department of Health & Human Services (HHS), and Congress can take to increase diversity in clinical trials. Legal estrangement is a theory that represents detachment and alienation from those who created the law. From February to March 2023, researchers reviewed legal and medical literature, news stories, and federal regulations to identify barriers contributing to limited diversity in clinical trials. Using the legal estrangement theory as an overarching guide, three broad themes across the clinical trials literature (i.e., procedural injustice, vicarious marginalization, and structural exclusion) were identified. Procedural injustice refers to when people perceive not being treated with dignity and respect. Vicarious marginalization refers to negative experiences that collectively contribute to feelings of alienation. Structural exclusion refers to the way policies that seem to be race or class-neutral have disproportionate effects on marginalized communities. We found that researcher implicit bias and stereotyping contribute to procedural injustice and vicarious marginalization by discouraging prospective people from joining clinical trials. Structural barriers like inaccessibility to participant-friendly educational materials, ambiguity in grant reporting requirements, lack of strong substantive grant standards, exclusion of LGBTQI+ individuals from grant enrollment reports, and budgetary constraints limit efforts to increase participant diversity in clinical trials. To improve diversity in clinical trials, we recommend improving transparency and communication, building meaningful partnerships with community leaders, requiring cultural competency training for researchers, incorporating automatic and non-autonomic recruitment strategies to circumvent bias, strengthening substantive NIH grant standards, adding gender identities to grant enrollment reports, and requesting greater Congressional funding for clinical trials research. Thus, to improve diversity in federally funded clinical trials, a multi-faceted approach that involves researchers, academic institutions, community members, HHS, and Congress are recommended to reduce procedural injustice, vicarious marginalization, and structural exclusion. Future research is needed to explore the connection between structural barriers to access to clinical trials and disparities in cancer care management and patient outcomes.
Citation Format: Cilgy M. Abraham, Denalee M. O'Malley. Mapping the legal estrangement theory onto known barriers in recruiting diverse participants to clinical trials [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A133.