Understanding the role of social determinants on clinical trial participation and trust.
The Michael J. Fox Foundation for Parkinson’s Research (MJFF) aims to speed clinical research by removing obstacles that stand in the way of drug development. In pursuit of this mission, the Foundation gathers insights from a wide range of stakeholders and uses these perspectives to enhance clinical trial processes from start to finish. In Applied Clinical Trials’ Eye on Patient Advocacy series, we will share best practices and lessons learned from the field of Parkinson’s research that can be applied to clinical trials across disease states. In our latest column in this series, we discuss the dearth of research connecting social determinants to mistrust and distrust of clinical trials, and one study’s efforts to connect these dots.
Marginalized groups in the US, such as Black, Indigenous, Latinx, and transgender persons, have been historically neglected and systematically excluded in clinical trial participant recruitment. This exclusion is despite federal regulations that mandate the inclusion of women and other minorities in clinical trials.1-3 Recruitment strategies rarely prioritize the aforementioned marginalized groups in clinical trials despite evidence-based approaches such as sustained community education and engagement.4 Instead, researchers have continued to attribute the lack of diversity in clinical trials to the mistrust of marginalized communities.1,5 Mistrust is the belief that an individual from a marginalized group will not receive quality or fair treatment based on a history of maltreatment toward marginalized communities.5,6 However, interdisciplinary literature suggests social determinants—including poverty, segregation, food insecurity, and structural racism—not only produce poor experiences of health, but also a distrust of health research in general.5,7,8 Distrust refers to the suspicion that a specific provider, researcher, or institution can poorly treat or harm an individual from a marginalized group based on specific examples of discrimination or misconduct.5 Recent discussions on vaccine hesitancy have rightfully directed attention toward historic examples of misconduct toward Black communities. There are also historic reasons for distrust in Indigenous, Latinx, and transgender communities, which include imperialization, forced sterilization, and poor healthcare delivery.9-11 Hence, there is reason to believe that social determinants drive inclusion in clinical trials as well as trust.12-14
Some literature suggests discriminatory experiences with other institutions—including law enforcement, housing, and schools—contribute to mistrust and distrust.15,16 For instance, as incarceration rates indicate, the burden of social injustice disproportionately impacts Black, Latinx, and transgender communities.17,18 Similarly, the recent forced sterilization of Latinx persons at the US/Mexico border presents another example of structural racism and institutional complicity.6,19,20 Interestingly, while there is strong evidence that mistrust and distrust contribute to lack of clinical trial participation for Black, Indigenous, Latinx, and transgender persons, there is also a dearth of research connecting mistrust, distrust, and clinical trial participation to social determinants. Additionally, there has not been an exploration of how Black, Indigenous, Latinx, and transgender persons, who have participated in clinical trials, have navigated barriers like social determinants and trust.
The Trials and Trust/Investigación y Confianza study seeks to connect the dots from social determinants to clinical trial participation using narrative storytelling. Trials and Trust/Investigación y Confianza is a qualitative study collecting 40 narratives of Black, Indigenous, Latinx, and transgender persons currently living in the US and its territories who successfully completed clinical trials between 2010-2020. Participants are recruited through long-standing relationships the research team has with Black, Indigenous, Latinx, and transgender communities, as well as disease-specific research centers, community neurology centers, community health centers, foundations, support groups, adult day cares, nursing homes, and community-based organizations. The study is advertised in both English and Spanish using culturally-responsive content and media. Using semi-structured in-depth interviews, participants share the barriers to clinical trial participation that they faced and key facilitators that supported their completion. To explore the potential intersecting role of disease prognosis in motivation to participate in a clinical trial, the Trials and Trust/Investigación y Confianza study focuses on neurological conditions without effective treatments such as Parkinson’s disease, Alzheimer’s disease, and related dementias. The expected findings of this exploratory research include (1) a description of the impact of social determinants over the life course on mistrust, distrust, and clinical trial participation, (2) an understanding of the facilitators of clinical trial participation for individuals impacted by social determinants, and (3) a preliminary idea of how disease prognosis plays a role in the decision to participate in a clinical trial.
Trials and Trust/Investigación y Confianza uniquely takes an emic approach to research by centering the voices of marginalized communities. Trials and Trust/Investigación y Confianza utilizes a novel approach to research by focusing on the successful completion of clinical trials by marginalized group members, further emphasizing the importance of diverse perspectives in clinical research. In addition, by engaging community stakeholders and returning the findings to communities, this study ensures the bidirectionality of research benefit for scientific and lay community alike. Lastly, by identifying barriers and key facilitators to clinical trial participation, The Trials and Trust/Investigación y Confianza Study will not only contribute to delineating the pathway to clinical trial participation for Black, Indigenous, Latinx, and transgender persons; findings from this study will also assist the research community with addressing social determinant barriers for future studies as this may increase diverse participation in health research.
For more information on Trials and Trust/Investigación y Confianza, contact the study’s principal investigator, Dr. Paris Adkins-Jackson, at firstname.lastname@example.org, and co-Investigator, Dr. Angie Sanchez, at email@example.com.
—Authors of this report: Paris “AJ” Adkins-Jackson, PhD, MPH; Angie Sanchez, MD; and Juliana Ison; all with CARE Research Center-Massachusetts General Hospital; and Samantha S. Williams-Gray, Meridian University
This study is supported by The Michael J. Fox Foundation, Genentech, a member of the Roche group, and Boston University’s Alzheimer’s Disease Research Center.
The MJFF Research Engagement Team includes James Gibaldi, MS, Associate Director; Tara Hastings, Senior Associate Director; Catherine M. Kopil, PhD, Director; Bernadette Siddiqi, MA, Associate Director; and Michelle Whitham, Research Partnerships Officer at The Michael J. Fox Foundation in New York, NY. To contact the MJFF Research Engagement Team, email: firstname.lastname@example.org
The Systemic Synuclein Sampling Study (S4) was a multicenter, cross-sectional, observational study sponsored by MJFF. The primary objective of this study was to better understand the progression of Parkinson’s disease (PD) by identifying the optimal biofluids and tissues for measuring the protein alpha-synuclein outside of the brain as a potential biomarker in individuals with PD. The secondary objective of the study was to create standard operating procedures for the collection and assessment of multiple tissues and biofluids to better understand alpha-synuclein’s potential as a biomarker for PD.
In January 2017, MJFF launched a survey to assess the need for transportation infrastructure at clinical trial sites. Data from the survey was used to inform the design of a transportation intervention that was tested via the Parkinson’s Disease Trial Recruitment Innovation (PD-TRI) project, an MJFF-funded pilot study aimed at reducing barriers and enhancing facilitators to clinical trial recruitment.
Patient retention is an important element of the Parkinson’s Progression Markers Initiative (PPMI), a landmark, longitudinal, observational study sponsored by MJFF. PPMI aims to find reliable and consistent biomarkers for PD progression by studying cohorts of Parkinson’s patients, populations at risk for PD, and controls without PD.
Although the barriers to PD clinical research among underrepresented groups (URGs) have been well identified, it remains unclear whether suggested interventions will improve engagement of traditionally underrepresented populations in PD research. For these reasons, MJFF sponsored the Fostering Inclusivity in Research Engagement for Underrepresented Populations in Parkinson’s Disease (FIRE-UP PD) Study to 1) explore whether it is possible to identify best practices to engage URGs in PD clinical research, 2) to assess knowledge and attitudes toward clinical research designs, and 3) to increase participation of URGs to Fox Insight.