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- Title
Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical Trials.
- Authors
Florez, Maria I.; Botto, Emily; Kim, Jennifer Y.
- Abstract
This survey study examines the extent to which for-profit and nonprofit or governmental clinical research sites use strategies to recruit trial participants from socioeconomically disadvantaged groups. Key Points: Question: What strategies do research sites use to recruit clinical trial participants from socioeconomically disadvantaged groups, and does implementation of these strategies differ between for-profit and nonprofit or governmental sites? Findings: This survey study, which was based on 492 responses from 381 US clinical research sites, found that compared with nonprofit or governmental sites, for-profit sites more often used strategies associated with increased recruitment of socioeconomically disadvantaged patients. Meaning: Study findings suggest that adoption of strategies to gather socioeconomic data and increase accessibility to clinical trials may help minimize barriers to participation among socioeconomically disadvantaged patients. Importance: Socioeconomically disadvantaged patients, such as persons with low income and those with low educational attainment, are less likely to participate in clinical trials than those with higher earnings and higher educational attainment, despite the former being more likely to have chronic medical conditions. Ways to improve the representation of socioeconomically disadvantaged patients in clinical trials deserve attention. Objective: To examine whether current recruitment and enrollment strategies used by US clinical research sites appropriately include patients from socioeconomically disadvantaged backgrounds. Design, Setting, and Participants: This survey study was conducted between April and July 2023. An online survey was distributed among US clinical research sites to explore their use of these strategies and the types of patient sociodemographic and socioeconomic data they collect. The survey was distributed by 13 pharmaceutical companies and 1 clinical research organization. Eight targeted strategies known to increase the recruitment and retention of socioeconomically disadvantaged participants as well as 6 general strategies to recruit and retain clinical trial participants were identified. Data analysis was performed between August and September 2023. Main Outcomes and Measures: Proportions of for-profit vs nonprofit or governmental sites that use recruitment and retention strategies, proportions that have partnerships with community organizations that target socioeconomically disadvantaged groups, and the distribution of sociodemographic and socioeconomic data collected by sites about their patients. A χ2 test of independence was performed to assess the association between research site ownership type and levels of adoption of strategies. Results: A total of 492 responses were collected from 381 clinical research sites in the US (219 for-profit sites [57.5%] and 162 nonprofit or governmental sites [42.5%]). Overall, compared with nonprofit or governmental sites, for-profit sites reported higher use of strategies shown to increase the recruitment and retention of socioeconomically disadvantaged populations, including always or often providing after-hours visits (84 of 173 for-profit sites [48.6%]; 22 of 123 nonprofit or governmental sites [17.9%]) and offering financial compensation (135 of 162 for-profit sites [83.3%]; 60 of 123 nonprofit or governmental sites [48.8%]). Additionally, there was an association between research site ownership type and levels of adoption of these strategies; for example, for-profit sites were more likely to provide after-hours visits (χ2 = 30.33; P <.001) and offer financial compensation (χ2 = 49.35; P <.001). Only 7.2% of for-profit sites (12 of 167) and 13.0% of nonprofit or governmental sites (16 of 123) collected information on the patient's annual income. Conclusions and Relevance: In this survey study, we found an association between a clinical research site's ownership type (for-profit vs nonprofit or governmental) and how often it used strategies to engage socioeconomically diverse populations in clinical research. Regardless of ownership type, most clinical research sites did not collect socioeconomic information from patients. Adoption of strategies to engage socioeconomically diverse populations, particularly by nonprofit or governmental sites, may help minimize barriers to participation for socioeconomically disadvantaged patients.
- Subjects
UNITED States; PATIENT selection; PROPRIETARY health facilities; NONPROFIT organizations; RESEARCH funding; CLINICAL trials; HUMAN research subjects; SOCIOECONOMIC status; AT-risk people; SOCIOECONOMIC factors; CHI-squared test; DESCRIPTIVE statistics; SURVEYS; SOCIODEMOGRAPHIC factors; DATA analysis software; PUBLIC administration; SOCIAL classes
- Publication
JAMA Network Open, 2024, Vol 7, Issue 6, pe2413962
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.13962