Abstract
Objective
We explored facilitators influencing participation in randomized clinical trials (RCTs) among underrepresented groups in the United States, including Black and Hispanic/Latinx individuals, women, and rural populations.
Methods
We recruited a convenience sample of adults from these underrepresented groups to complete an online survey of multiple-choice and open-ended questions about preferences and motivations for RCT participation. Recruitment occurred May through September 2023.
Results
Facilitators included regular communication, minimizing participant burden, building trust, fair compensation, and emphasizing the purpose and value of research.
Conclusion
To improve inclusivity and generalizability, addressing the barriers to RCT participation for underrepresented groups is crucial. Our results point to the importance of designing RCTs that prioritize transparency, clearly define the research objectives, reduce participant burden, and cultivate trust, while ensuring that compensation and logistical support are equitable and reflect participants' time and effort.
Keywords: Diversity, equity, and inclusion; Health equity; Social justice; Research priorities; Practice guidelines; Randomized clinical trials; Recruitment; Retention; Underrepresented populations; Health disparities; Black, Hispanic/Latinx; Women; Rural populations; Mixed methods
1. Introduction
Randomized clinical trials (RCTs) depend on diverse participants for external validity; however, people from historically marginalized populations are often excluded from RCTs (Habibzadeh, 2022; Flores et al., 2021; Ranganathan and Bhopal, 2006). In particular (Arevalo et al., 2016), Black, Hispanic/Latinx, women, and rural populations (Balla et al., 2020; George et al., 2014; Mouton et al., 2017) remain underrepresented across RCTs (Carlisle et al., 2015). This has led to a significant gap in understanding how interventions may vary in their effectiveness across diverse populations (Preventza et al., 2021a; Arevalo et al., 2016). Systemic barriers, including mistrust of the biomedical community, lack of awareness, time constraints, language barriers, and caregiver responsibilities, exacerbate the underrepresentation of historically marginalized groups in RCTs (Balla et al., 2020; George et al., 2014; Mouton et al., 2017). Therefore, we sought to assess preferences for recruitment, participation, and engagement with RCTs among historically underrepresented groups.
2. Methods
2.1. Study design and population
We recruited a convenience sample of patients in clinical waiting areas (cardiology, pulmonology, oncology, and radiology clinics, emergency departments, digital signs across hospitals) and at a community-based organization that served Spanish speaking clients. Participants reflected the populations who would be approached to participate in RCTs in these settings. Inclusion criteria included adults who identified as Black, Hispanic/Latinx, women, and/or living in rural areas and who were able to read English and/or Spanish across five United States health systems within the Washington DC, Philadelphia, and Atlanta metro areas, and one community-based organization serving the health and wellness needs of the Hispanic/Latinx population of Philadelphia from May through September 2023. Using a QR code linked to an online Qualtrics survey, participants first completed an eligibility questionnaire, followed by an informed consent form among eligible participants, followed by five multiple-choice and eight open-ended questions focused on preferences about RCT participation among those who consented.
2.2. Measures
Multiple choice questions examined participants' preferences and comfort with different modes of contact for RCT recruitment, motivations for and barriers to RCT participation, and factors that might facilitate RCT recruitment and participation. Open-ended questions asked participants to describe what actions researchers should or should not take when recruiting for RCTs, explain what factors would make them more or less likely to participate in a study, and share how they preferred to be contacted for recruitment. The survey instrument was developed by the research team, including experts in survey design. The survey was pilot tested with five staff members who were not part of the research team, who provided edits and feedback.
Participants completed surveys in 20 min or less and were offered a $25 incentive for completing the survey. Respondents could choose from the following payment options: PayPal,
Venmo, Zelle, or an e-gift card to a drug store or local convenience store.
The study followed ethical guidelines and was approved by the University of Pennsylvania Institutional Review Board (Protocol 851,603).
2.3. Analysis
We conducted parallel analyses of the quantitative and qualitative data (Zoellner and Harris, 2017). We analyzed data by respondent group; respondents who identified with multiple groups (e.g., a woman living in a rural area) contributed data to each relevant group's analysis. The qualitative data were subsequently aggregated across groups because of response overlap.
To identify emergent themes and develop a codebook, the analytic team (JD, MM, EBF, SC) independently reviewed and open-coded all open-ended responses from the first 18 completed surveys and met weekly to discuss key findings. Once a preliminary codebook was established and the survey was closed, all responses to open-ended questions were imported into ATLAS.ti to facilitate coding and thematic analysis. The qualitative analysis team (JD, MM, EBF, SC) was trained and supervised by a qualitative research specialist (JAS). Weekly meetings were held to consensus code all open-ended responses, refining the codebook as needed. Coded data were organized into theme sheets for further analysis.
Data were analyzed by respondent group, including both a summary of salient themes and key suggestions and preferences. Survey results were categorized by qualitative themes to align conceptual themes with pragmatic priorities. Throughout the process, a thematic matrix was used to help organize sub-themes across various codes and identify the overlap between groups. Responses were highly consistent between groups, and results were aggregated into a summary of suggestions. Quantitative data were analyzed in R, and qualitative data were analyzed in Atlas.ti.
3. Results
Ninety-seven participants completed the survey and answered the open-ended questions (Fig. 1). Most respondents were Black (n = 55; 56.7%), and a majority were non-Hispanic/Latinx (n = 75; 77.3%). Most respondents identified as women (n = 77; 79.4%), and 45 respondents (46.4%) identified as residing in a rural area.
Fig. 1.
Consort diagram of participants who completed a survey about participation in clinical trials.
3.1. Regular communication
Survey data showed that participants preferred email (n = 64; 67.4%) and text message (n = 50; 52.6%) recruitment, with in-person recruitment (n = 19; 20%) being the least preferred (Table 1). Forty-four respondents (46.3%) favored research staff recruiters (n = 44; 46.3%) or their regular healthcare clinicians (n = 39; 41.1%). Black participants (n = 27; 50%) were most likely to prefer both compared to other respondents. Sharing study results was especially important to Hispanic/Latinx participants (n = 44; 57.1%). Participants wanted clear and effective communication; comprehensive information about the study's purpose, risks, and benefits; ample time to consider information; and brevity and clarity of communication. Other priorities included receiving regular feedback and updates to ensure they felt included and valued in the research; detailed information about the study; prompt replies to questions; and receiving results at the conclusion of the study (Table 2).
Table 1.
Preferences for RCT recruitment among underrepresented adults in the United States in 2023.
| All (N = 95) |
Black (N = 54; 56.8%) |
Hispanic/Latinx (N = 21; 22.1%) |
Women (N = 75; 78.9%) |
Rural (N = 43; 45.3%) |
|
|---|---|---|---|---|---|
| Here are some ways we contact people to participate in a research study. Would you be okay with someone contacting you to participate in a research study these ways? (Please check all that apply): | |||||
| Phone | 35 (36.8%) | 22 (40.7%) | 8 (38.1%) | 27 (36.0%) | 17 (39.5%) |
| Text | 50 (52.6%) | 26 (48.1%) | 10 (47.6%) | 42 (56.0%) | 24 (55.8%) |
| 64 (67.4%) | 32 (59.3%) | 16 (76.2%) | 48 (64.0%) | 31 (72.1%) | |
| 32 (33.7%) | 17 (31.5%) | 5 (23.8%) | 29 (38.7%) | 13 (30.2%) | |
| In person | 19 (20.0%) | 8 (14.8%) | 5 (23.8%) | 18 (24.0%) | 9 (20.9%) |
| Online portal | 22 (23.2%) | 7 (13.0%) | 4 (19.0%) | 19 (25.3%) | 10 (23.3%) |
| Other | 4 (4.2%) | 3 (5.6%) | 0 (0.0%) | 3 (4.0%) | 0 (0.0%) |
| You checked “in person” above. That means you would be okay if someone approached you in person about participating in a research study. Where would you feel most comfortable being approached in person about participating in a research study? (Please check all that apply): | |||||
| During appointments | 16 (84.2%) | 7 (87.5%) | 3 (60.0%) | 15 (83.3%) | 7 (77.8%) |
| In waiting room | 10 (52.6%) | 3 (37.5%) | 4 (80.0%) | 10 (55.6%) | 4 (44.4%) |
| In community spaces | 7 (36.8%) | 3 (37.5%) | 2 (40.0%) | 7 (38.9%) | 4 (44.4%) |
| I would like the person who asks me to participate in research be similar to me in the following ways: | |||||
| Race | 30 (31.6%) | 24 (44.4%) | 4 (19.0%) | 24 (32.0%) | 16 (37.2%) |
| Ethnicity | 16 (16.8%) | 13 (24.1%) | 2 (9.5%) | 12 (16.0%) | 6 (14.0%) |
| Gender | 26 (27.4%) | 18 (33.3%) | 4 (19.0%) | 20 (26.7%) | 12 (27.9%) |
| Locality | 13 (13.7%) | 8 (14.8%) | 3 (14.3%) | 10 (13.3%) | 5 (11.6%) |
| Language | 46 (48.4%) | 25 (46.3%) | 12 (57.1%) | 37 (49.3%) | 19 (44.2%) |
| Other | 9 (9.5%) | 6 (11.1%) | 1 (4.8%) | 9 (12.0%) | 2 (4.7%) |
| Who do you prefer to ask you to participate in a research study? Ignore how similar or different they are (or seem to be) from you. | |||||
| Research staff | 44 (46.3%) | 27 (50.0%) | 11 (52.4%) | 32 (42.7%) | 19 (44.2%) |
| Healthcare staff | 21 (22.1%) | 15 (27.8%) | 4 (19.0%) | 16 (21.3%) | 9 (20.9%) |
| Regular healthcare clinician | 39 (41.1%) | 27 (50.0%) | 4 (19.0%) | 32 (42.7%) | 19 (44.2%) |
| Other healthcare clinician | 16 (16.8%) | 12 (22.2%) | 1 (4.8%) | 14 (18.7%) | 7 (16.3%) |
| Community member | 17 (17.9%) | 11 (20.4%) | 5 (23.8%) | 14 (18.7%) | 7 (16.3%) |
| No preference | 24 (25.3%) | 7 (13.0%) | 7 (33.3%) | 21 (28.0%) | 11 (25.6%) |
| What type(s) of support would make it more likely that you participate in a research study? (Do not include money.) | |||||
| Meals | 52 (54.7%) | 31 (57.4%) | 11 (52.4%) | 42 (56.0%) | 24 (55.8%) |
| Childcare | 24 (25.3%) | 16 (29.6%) | 3 (14.3%) | 18 (24.0%) | 11 (25.6%) |
| Results shared | 44 (46.3%) | 18 (33.3%) | 12 (57.1%) | 37 (49.3%) | 20 (46.5%) |
| Transportation voucher | 49 (51.6%) | 27 (50.0%) | 12 (57.1%) | 36 (48.0%) | 23 (53.5%) |
| Material prizes | 49 (51.6%) | 24 (44.4%) | 12 (47.6%) | 35 (46.7%) | 21 (48.8%) |
| Social recognition | 21 (22.1%) | 10 (18.5%) | 6 (28.6%) | 17 (22.7%) | 10 (23.3%) |
| More accommodating times | 41 (43.2%) | 23 (42.6%) | 6 (28.6%) | 35 (46.7%) | 20 (46.5%) |
Table 2.
Exemplary quotes from underrepresented adults in clinical trials in the United States in 2023.
| Theme | Quotes |
|---|---|
| Recruitment and communication throughout the study | Be clear about the time commitment, compensation, and qualifying factors. (191: Woman) [Do not] shut us out, keeping secrets about the project, not giving updates on the work. (255: Hispanic/Latinx, Rural) Fully disclose what is going to happen. (224: Hispanic/Latinx, Woman) |
| Minimizing participant burden | Simplify paperwork, streamline enrollment, provide childcare, and provide mobile/satellite options for mid-study checking for participants outside a 30-min travel radius. (271: Woman) Make it easily accessible if in person, make it at a more convenient time for those who have to work 9–5. (126: Hispanic/Latinx, Woman) |
| Building trust with participants | Always speak the truth and explain the purpose for the research. Regarding the data obtained by the participants, it must be kept private and, if required to publish the findings, request authorization to share them. (221: Hispanic/Latinx, Woman) Be honest with participants. (141: Black, Woman) Being treated poorly by researchers. The prospect of being uncomfortable or unsafe. The possibility of being harmed. (116: Woman) |
| Fairly compensating participants | If I am being paid for my time, then this is a bonus because I am taking the time out to help, so being compensated shows appreciation. (148: Black, Woman) |
| Emphasizing the purpose and value of research | All depends on the research! Is it beneficial to me? (149: Black, Woman) Reassurance that the research study is legitimate and is intended to help people. (116: Woman) |
3.2. Minimizing burden
Respondents felt that personal responsibilities could impede their ability to participate in a trial, but they could be offset by offering incentives. Motivators for RCT participation included meals (n = 52; 54.7%), transportation vouchers (n = 49; 51.6%), and, for some respondents, childcare (n = 24; 25.3%). Participants expressed a desire for simplified, shorter questions to make the research process manageable; the option for online studies; and flexibility in scheduling and addressing logistical challenges by simplifying paperwork, streamlining enrollment, providing childcare, and offering transportation or mobile options for participants living far from the study site.
3.3. Building trust with participants
Trust was a critical factor for participants to both participate and remain in a research study. Language concordance between study staff and participants was the most important motivating factor for 46 (48.4%) participants, with higher preferences among Hispanic/Latinx participants (n = 12; 57.1%). In addition to building trust through shared language, participants wanted to feel safe, respected, and informed throughout the research process. They also prioritized clear, simple explanations of the study's purpose and thorough answers to their questions. Researchers should avoid misleading information or uncommunicated elements that could cause distrust, and they should be knowledgeable, open, and non-deceitful. Responses to concerns should be handled ethically. Participants should remain anonymous, and explicit consent for using their information must be obtained. Respondents also preferred a welcoming, engaging, and non-intimidating environment, transparency, and respect for privacy and safety.
3.4. Fair compensation
Participants felt that monetary compensation should reflect the time, effort, and potential risks involved in the study. Most participants (n = 49; 51.6%) valued material prizes.
They emphasized the need for equitable payments and consideration of travel costs, time away from work, and other inconveniences. Participants wanted clear communication about compensation as well as partial payments for those who undergo screening but do not qualify for the study, and compensation for time spent on a study (regardless of the length). Payments should be dependent on the length of study participation.
3.5. Emphasizing the purpose and value of research
Beyond financial incentives, participants expressed a desire to understand the purpose and value of the research. Several respondents identified social recognition (n = 21; 22.1%) as a motivator for participation. They wanted to know how the study's goals, outcomes, and potential benefits would impact them and/or society, assurance about the study's legitimacy and practicality, and to be informed about the study's objectives and potential benefits, whether health-related or financial.
4. Discussion
The results of this study align with the current discourse on RCT enrollment and retention which has shown that underrepresented groups in RCTs encounter various barriers to participation (Balla et al., 2020; Rhodes et al., 2018; Cho et al., 2021; Clark et al., 2019; Levit et al., 2020; Crenshaw, 1989; Preventza et al., 2021b; Chen and Li, 2021; Wallace et al., 2023; De Bekker-Grob et al., 2012). We add to this foundational work by identifying specific factors that marginalized participants consider when they are invited to participate in research, as well as factors that influence their continued engagement once enrolled. These factors go beyond the commonly recognized barriers of awareness, mistrust, and logistical constraints, revealing deeper concerns related to communication, participant burdens, compensation, and the value that the research provides both to them individually as well as to society.
These findings highlight the need for trial strategies tailored to address these concerns but also emphasize the role of historical systemic oppression and exclusion in shaping participants' experiences, particularly for those belonging to multiple marginalized groups. As a result, our findings provide actionable recommendations for researchers to improve both recruitment and retention of underrepresented groups in RCTs, ultimately fostering greater inclusivity and improving the generalizability of clinical research.
Participants highlighted several key preferences for recruitment, participation, and engagement with RCTs. Researchers should acknowledge participant preferences for communication such as using SMS and email, as well as their desire to receive regular communication and learn about the results at the conclusion of the study. Study teams should additionally consider logistical challenges when scheduling study visits, including financial support for transportation and childcare which may reduce participant burden. Language concordance between participants and recruiters and clear explanations of the study's purpose, addressing ethical concerns, and assuring participants that their data will be handled responsibly foster trust and may increase participation and engagement. Moreover, centering the value of research to participants—demonstrating how their involvement contributes to a broader societal good—can enhance motivation and willingness to participate. Compensation should be equitable, transparent, and reflective of the time commitment required, with partial payments for screening processes to honor all contributions.
Our results only reflect the experiences and opinions of specific individuals from a convenience sample in our four groups of interest. Additionally, participants had to have a smartphone and know how to scan a QR code to enroll, which may have skewed respondents to those with technological literacy; although 90% of Americans own a smartphone (Demographics of Mobile Device Ownership and Adoption in the United States | Pew Research Center, 2026) those without one were excluded and may represent a relevant population. Future work is needed to understand the experiences and preferences of other marginalized groups underrepresented in research, including people who identify as Asian, those with disabilities, and transgender and non-binary individuals, as well as across intersectional groups.
5. Conclusions
To improve inclusivity and generalizability, addressing the barriers to RCT participation for underrepresented groups is crucial. Our results point to the importance of designing RCTs that prioritize transparency, clearly define the research objectives, reduce participant burden, and cultivate trust, while ensuring that compensation and logistical support are equitable and reflect participants' time and effort.
Studies in Human
This study was performed in compliance with relevant laws, regulatory frameworks and guidelines where the research took place.
This study was approved by the University of Pennsylvania.
(Approval No. 851603)
CRediT authorship contribution statement
Josiah Drakes: Writing – original draft, Formal analysis. Medha Romee Maitra: Writing – original draft, Data curation. Jasmine A. Silvestri: Writing – review & editing, Writing – original draft, Formal analysis. Emma Britez Ferrante: Writing – review & editing, Formal analysis. Dorothy Sheu: Writing – review & editing, Conceptualization. Sebastian Castro: Formal analysis, Data curation. Adina Lieberman: Writing – review & editing, Supervision, Project administration. Scott Halpern: Methodology, Investigation, Funding acquisition, Conceptualization. Meghan Lane-Fall: Writing – review & editing, Project administration, Methodology. Rachel Kohn: Writing – review & editing, Supervision. Tamar Klaiman: Writing – review & editing, Supervision, Formal analysis.
Informed consent and patient details
Verbal informed consent to take part in the study and to publish the article has been obtained from all participants or their legal representatives. The privacy rights of participants have been observed.
Funding statement
This project was funded by the American Heart Association Strategically Focused Research Network on the Science of Diversity in Clinical Trials (946224). The American Heart Association played no role in the performance or interpretation of this study.
Declaration of competing interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Lane-Fall is a paid educational consultant for Janssen Pharmaceuticals and Medtronic. Dr. Kohn is a paid consultant for MDCalc and previously consulted for Meta. The remaining authors declare no competing interests.
Acknowledgments
We thank Jenny Tian, BA and Casey Whitman, MS for their help with statistical analysis and data management.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.pmedr.2026.103653.
Appendix A. Supplementary data
Supplementary material
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