Pediatric Oncology Clinical Trial Participation Among Families From Historically Marginalized Groups

Key Points

Question

What are perceived barriers and facilitators to pediatric oncology clinical trial participation among families from historically marginalized groups?

Findings

In this cross-sectional study of 60 parents of Black and Hispanic children and 15 clinicians, parents and clinicians converged on facilitators (altruism and trustworthiness) and some barriers (informed consent discussion, non-English language preference, trial materials, and study requirements). Clinicians viewed experimentation in trials and household material hardship as barriers that also prompted gatekeeping, whereas parents did not view these concerns as prohibitive.

Meaning

The findings of this study suggest that systematic screening for trial eligibility and household material hardship may reduce clinician gatekeeping and facilitate equitable trial enrollment.

This cross-sectional study collects and analyzes clinician and parent perspectives on pediatric oncology clinical trial participation among children from historically marginalized groups.

Abstract

Importance

Perspectives of families from historically marginalized groups regarding pediatric oncology clinical trial participation are not well-represented in the literature.

Objective

To describe clinician- and parent-perceived facilitators and barriers to clinical trial participation.

Design, Setting, and Participants

This single-center cross-sectional study with an explanatory sequential mixed-methods design enrolled parents of Black and Hispanic children with cancer as well as pediatric oncology clinicians from a large pediatric cancer center in Boston, Massachusetts. Parent participants completed single–time point surveys, and a subset, purposively sampled based on self-identified race and ethnicity, language, and household material hardship (HMH; ie, food, housing, transportation, or utility insecurity), completed semistructured interviews from September to December 2021. Clinicians completed semistructured interviews from February to March 2022. Data were analyzed from April 2022 to October 2025.

Main Outcomes and Measures

Key factors influencing clinical trial participation in pediatric oncology among parents from historically marginalized groups. Quantitative data were summarized descriptively. Interview transcripts were analyzed using thematic analysis and integrated along key domains.

Results

A total of 60 parents completed the questionnaire; self-identified race and ethnicity included 5 Hispanic Black (8%), 10 Hispanic White (17%), 21 Hispanic other (35%), 21 non-Hispanic Black (35%), and 3 non-Hispanic White (5%) parents; most were mothers (51 [85%]). Twenty parents participated in interviews. Fifteen clinicians (10 [67%] female participants; 10 [67%] with ≥10 years caring for children with cancer) were interviewed, including 12 (80%) attendings and 3 (20%) advanced practice practitioners; most identified as non-Hispanic White (14 [93%]). Most families experienced HMH (44 [73%]) and reported high trust in their oncology team (mean [SD] score, 4.63 [0.65] of 5.00). Qualitatively, parents and clinicians aligned in identifying altruism and trustworthiness as facilitators to trial participation, while the informed consent discussion, non-English language preference, trial materials, and study requirements were participation barriers. Unlike clinicians, parents did not identify HMH or the experimental nature of trials as significant barriers to participation. Parents identified the desire for representation as a facilitator to participation, and clinicians identified gatekeeping as a barrier.

Conclusions and Relevance

In this cross-sectional study of pediatric oncology families from historically marginalized groups and clinicians, clinician- and parent-perceived barriers identified opportunities to increase equitable trial participation. Next steps include standardization of trial eligibility screening and systematic HMH screening and support to reduce gatekeeping.

Introduction

Over the last 75 years, survival for children with cancer has improved from less than 10% to more than 85% due to in part to cooperative group clinical trials.¹ Unfortunately, Black and Hispanic children with cancer experience worse survival compared with White children despite these advances.^2,3,4,5

Trial participation may improve outcomes for Black and Hispanic children through several mechanisms. First, trial participation provides access to highly standardized treatment, which may confer a survival benefit.^6,7,8,9 Second, diverse representation ensures that findings are generalizable to historically marginalized populations and allows investigators to identify contributors to poor outcomes—essential steps to mitigating disparities and improving outcomes.^10,11 Third, representation in clinical trials promotes trustworthiness of modern medical advances.¹⁰ Recognizing these benefits, equitable access to clinical trials has become a national priority.¹²

In pediatric oncology, some studies suggest disparate trial enrollment, with Black and Hispanic children enrolling at lower rates than White children,^13,14 while others suggest proportional enrollment across race and ethnicity.^15,16 Black and Hispanic children with cancer experience inferior survival despite participation in clinical trials, suggesting that access to highly standardized treatment alone does not overcome this disparity.^2,3,5,17 These data underscore the importance of representative trial participation to identify other mechanisms, such as ancestry-associated adverse biology, treatment toxic effects, or differential treatment receipt or response, driving racial and ethnic survival disparities. Yet, no contemporary pediatric oncology studies have focused on Black and Hispanic families’ perspectives regarding research participation. To address this, we conducted a cross-sectional study with a mixed-methods design to identify parent- and clinician-reported barriers and facilitators to clinical trial participation among Black and Hispanic families of children with cancer.

Methods

This single-center prospective cross-sectional study utilized an explanatory sequential mixed methods approach and followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline¹⁸ and the Consolidated Criteria for Reporting Qualitative Research (COREQ) reporting guideline.¹⁹ The Dana-Farber Cancer Institute (DFCI) institutional review board approved this study.

Study Population and Recruitment

Parent Participants

Eligible parents included English- and Spanish-speaking parents of children (1) younger than 18 years, (2) who identified as Black or Hispanic according to the electronic medical record (EMR) or the primary team, (3) who were 6 weeks post cancer diagnosis to 1 year off therapy, (4) who were receiving primary oncology care at DFCI/Boston Children’s Hospital (BCH), and (5) whose primary oncology team granted approval for approach. Child race and ethnicity identified in the EMR informed initial parent eligibility for the survey; thus, not all enrolled parents identified as Black or Hispanic. One parent per family was eligible. We a priori planned a convenience sample of 60 parents.

Eligible parents were sequentially mailed information letters with an opt-out option. The principal investigator (P.J.U.) or a trained clinical research coordinator (A.V.) approached eligible parents (in the clinic or hospital or by phone) to obtain consent. Consenting participants completed a single–time point survey. A subset who completed the survey were purposively sampled based on survey responses, including self-identified race and ethnicity, primary language, and household material hardship (HMH), and invited to participate in a semistructured interview; the goal was to interview parents who identified as Black and/or Hispanic, were Spanish-speaking, and had unmet basic resource needs due to a priori hypotheses about trial participation barriers. Parents received $15 gift cards for surveys and $25 gift cards for interviews.

Clinician Participants

Eligibility included pediatric oncology attendings and advanced practice practitioners (APPs) at DFCI/BCH with primary outpatient panels. This eligibility criteria reflected institutional-specific processes, where attending physicians, fellows, and APPs are responsible for treatment plan discussions, including all aspects of clinical trial enrollment from the decision to offer or not offer a trial, informed consent discussions, enrollment, and study reporting. Psychosocial clinicians and clinical research teams do not routinely participate in consent discussions. Clinicians were purposively sampled based on discipline and expertise in frontline vs early-phase trial therapy to provide a range of clinical trial experiences. Eligible clinicians received email invitations for participation and provided verbal informed consent prior to participation in a semistructured interview and a brief demographic survey. They received $25 gift cards for participation.

Data Collection

Parent Cohort

Parents completed a 66-item survey in English or Spanish via REDCap,^20,21 paper and pencil, or read aloud, per parent preference. The survey (eAppendices 1 and 2 in Supplement 1) included the following domains: (1) sociodemographic characteristics (caregiver role, race and ethnicity, language, education, household size, household income); (2) health literacy^22,23,24; (3) social support^25,26,27; (4) HMH (defined as food, housing, transportation, or utility insecurity)^28,29; (5) clinical trial participation; (6) decisional regret^30,31; (7) trust in the primary oncologist³²; (8) group-based medical mistrust^33,34; (9) everyday experiences of discrimination³⁵; and (10) future study participation.

Remote (phone or Zoom) semistructured interviews were conducted by the principal investigator (P.J.U. [if not involved in that family’s care]) or a qualitative scientist (A.C.R.) in English or Spanish per parent preference. The study team developed the interview guide (eAppendix 3 in Supplement 1) with key domains informed by the literature, clinical expertise, and survey data. Interviews focused on experience and decision-making regarding clinical trials, barriers and facilitators to participation, trust, and HMH. Interviews were audio-recorded, transcribed, and translated (when applicable). In-depth review and discussion by the team determined that meaning saturation³⁶ was achieved after 20 interviews, confirming that new interviews were not introducing additional meaningful dimensions or insights and that there were sufficient data for understanding key domains. EMR-collected data included child race and ethnicity, diagnosis and date, disease type, treatment, and whether the child was ever offered, ever enrolled, or currently on a clinical trial.

Clinician Cohort

Remote interviews were conducted by a qualitative scientist (A.C.R.); the guide (eAppendix 4 in Supplement 1) was based on the literature, clinical expertise, and parent-derived data. Key domains matched parent interviews to allow for analyses across and between groups. Interviews were audio-recorded, transcribed, and reviewed by the study team. In-depth review and discussion by the team determined that meaning saturation³⁶ was achieved after 15 interviews.

Statistical Analysis

Quantitative Analysis

Parent and clinician sociodemographics were summarized by descriptive statistics. Income as a percentage of the federal poverty level was calculated from parent-reported income and household size. Parent-reported HMH was summarized as a binary variable (≥1 domain present vs 0 domains) and by domain (food, housing, transportation, utilities). Means and SDs were calculated for the Trust in Oncologist scale (5-point Likert scale, with higher numbers indicating higher trust). Other quantitative measures will be reported elsewhere.

Qualitative Analyses

Four qualitatively trained team members (P.J.U., A.C.R., B.N.C., and A.V.) conducted thematic analysis.^37,38 Separate but overlapping codebooks were iteratively developed for parents and clinicians using deductive codes informed by the interview guide and survey data and inductive codes identified by transcript review and team discussion. The team coded all transcripts and resolved differences through recurrent meetings; the team discussed coded data with a focus on identifying barriers and facilitators to trial participation at multiple levels of influence (patient, clinician, and systems),³⁹ within- and cross-group (clinicians and parents) patterns, and areas of alignment and divergence. Analysis was supported by NVivo version 13 (QSR Interventional).⁴⁰

Mixed-Methods Integration

Quantitative and qualitative data were integrated at multiple points.⁴¹ Parent survey data informed the development and iterative refinement of the parent and clinician interview guides. Parents were purposively sampled based on survey responses. Quantitative and qualitative results were integrated along key domains to build a comprehensive understanding of specific barriers and facilitators for this patient population.

Results

Among 70 eligible parents, 69 were mailed study invites and 64 parents were approached (due to preplanned accrual goal). A total of 60 (94%) consented and completed the initial survey with minimal missing data. Overall, 20 of 24 parents (83%) completed the interview; 2 lost interest, 1 had a child die, and 1 was lost to follow-up.

Parent Cohort

Among 60 participants, 31 (52%) identified as Hispanic, with 10 (17%) Hispanic White and 21 (35%) Hispanic other parents; 5 (8%) identified as Hispanic Black; 21 (35%) as non-Hispanic Black; and 3 (5%) as non-Hispanic White. All interview participants identified as Hispanic (9 [45%]), Hispanic and Black (2 [10%]), or non-Hispanic Black (9 [45%]). Most survey respondents (51 [85%]) and interview participants (16 [80%]) were mothers (Table 1).

Table 1. Sociodemographic Characteristics for Participating Parents.

Characteristic	Participants, No. (%)
	Survey cohort (n = 60)	Interview subcohort (n = 20)
Parent characteristics
Parental role
Mother	51 (85)	16 (80)
Father	9 (15)	4 (20)
Race and ethnicity
Black, non-Hispanic	21 (35)	9 (45)
Black, Hispanic	5 (8)	2 (10)
Other, Hispanica	21 (35)	8 (40)
White, Hispanica	10 (17)	1 (5)
White, non-Hispanic	3 (5)	0
Primary language
English	35 (58)	12 (60)
Spanish	23 (38)	7 (35)
Other	2 (3)	1 (5)
Married or living with partner	37 (62)	15 (75)
High school diploma or more education	49 (82)	19 (95)
Health literacy
Confidence filling out medical forms
Not at all	0	0
A little bit	2 (3)	2 (10)
Somewhat	7 (12)	1 (5)
Quite a bit	19 (32)	8 (40)
Extremely	32 (53)	9 (45)
Problems learning about child’s medical condition due to difficulty understanding written information
Never	34 (57)	10 (50)
Occasionally	11 (18)	4 (20)
Sometimes	11 (18)	6 (30)
Often	1 (2)	0
Always	3 (5)	0
How often someone helps read hospital materials
Never	27 (46)	5 (25)
Occasionally	15 (25)	8 (40)
Sometime	5 (8)	6 (30)
Often	4 (7)	0
Always	8 (14)	0
HMHb
Any	44 (73)	15 (75)
Food	25 (42)	11 (55)
Housing	29 (48)	10 (50)
Transportation	15 (25)	5 (25)
Utilities	15 (25)	6 (30)
Household income <100% of the federal poverty linec	16 (39)	9 (47)
Trust in oncologist, mean (SD)	4.65 (0.65)	4.58 (0.91)
Child characteristics
Disease type
Hematologic malignancy	23 (38)	7(35)
Solid tumor	26 (43)	9 (45)
Brain tumor	6 (10)	3 (15)
Stem cell transplant	5 (8)	1 (5)
Actively receiving cancer-directed treatment	43 (72)	15 (75)
Ever participated in a clinical trial (parent-report)
Yes	27 (45)	9 (45)
No	22 (37)	8 (40)
Not sure	11 (18)	3 (15)
Ever participated in clinical trial (EMR report)
Yes	25 (42)	11 (55)

Abbreviations: EMR, electronic medical record; HMH, household material hardship.

^a The other, Hispanic group included 7 participants who chose “prefer not to respond” as their race and selected Hispanic ethnicity, 5 participants who chose “other” but did not specify or left race blank and selected Hispanic ethnicity, 8 participants who chose “other” and wrote in “Hispanic,” “Spanish,” or “Latino” for their race (and/or also selected Hispanic ethnicity), and 1 participant who chose American Indian or Alaska Native race and Hispanic ethnicity. All White, Hispanic, and other, Hispanic, participants are referred to as Hispanic in the article based on a priori decision to group participants in this way.

^b HMH includes insecurity in food, housing, transportation, or utilities.

^c Data missing for 19 patients.

Clinician Cohort

Of 16 approached, 15 clinicians (94%) consented to participation and completed interviews. Clinicians included 12 (80%) attendings and 3 (20%) APPs. There was 1 Asian clinician (7%) and 14 non-Hispanic White clinicians (93%). Most were female (10 [67%]) and had been in pediatric oncology practice for more than 10 years (10 [67%]) (Table 2).

Table 2. Sociodemographic Characteristics of Participating Clinicians.

Characteristic	Clinicians, No. (%) (n = 15)
Role
Attending	12 (80)
Nurse practitioner	3 (20)
Years caring for children with cancer, No.
0-3	0
4-6	2 (13)
7-10	3 (20)
≥10	10 (67)
Gender
Male	4 (27)
Female	10 (67)
Other or prefer not to respond	1 (7)
Race
Asian	1 (7)
Non-Hispanic White	14 (93)

Clinical Trial Experience Overall

By EMR, 28 of 60 families (47%) had been offered to enroll in a clinical trial, and of these, 25 (89%) enrolled. At the time of study participation, 20 parents (33%) had children actively on a clinical trial.

Qualitatively, both parents and clinicians identified that parental clinical trial decision-making weighed risks and/or benefits. Some parents participated because treatment was less intensive or had fewer potential late effects (such as no radiation). Other parents participated because trials offered opportunities for novel therapies or treatment schedules (eg, moving effective treatments earlier). Clinicians noted that parent-perceived risks may differ between frontline and early-phase trials (ie, higher risk tolerance with limited curative options).

Barriers and Facilitators

We identified key facilitators and barriers to trial participation organized by degree of convergence between parents and clinicians (Table 3) and presented conceptually by levels of influence at which these factors act (Figure).⁴² Quantitative data are presented when relevant.

Table 3. Parent- and Clinician-Identified Factors Influencing Clinical Trial Enrollment, by Alignment.

Factor	Parent illustrative quotes (participant identifier)	Clinician illustrative quotes (participant identifier)	Synthesized insight
Altruism	“We can help kids in the future which also makes you feel a little better too. So there was parts that—you know, we do extra bloodwork sometimes. Or they took extra fluid from her spine for research purposes. And we didn’t have to do that, but like I said, I mean, people did it for us probably ten years ago, so we are here now today doing” (Parent 16) “I think it’s very important that they further analyze…what it is, why it happened, what the cause is; like if they find any result, any important detail that they can tell the rest of the people who go through that process” (Parent 28) “Because I got to thinking about the fact that like me, there could be other mothers who need us so that they can better understand in the future” (Parent 32)	“I think many people are moved by the knowledge that it’s only through having done clinical trials in the past that we’ve arrived at the point where we are, in terms of understanding, and are willing to sort of pay it forward from an altruistic point of view and sort of contribute in any way to curing childhood cancer” (Clinician 8) “They say, will this information help future people in this situation? They now know firsthand how challenging this is and want to give back in some way and they will definitely articulate that” (Clinician 10)	Parents and clinicians thematically converged on altruism as a facilitator to participation.
Trustworthiness	“And I trust them from the beginning because the way they explained themselves about the whole treatment, and like I said, it does have to do a lot with the way you—the way they explain it to you, and it gives you—you feel like you can trust them” (Parent 36) “But I also did my research…. And how experienced she was as well. And I know that we’re in a great city for treatment, in general. And then [institution] also is high.… We ended up having a lot of trust in them after researching and having recommendations” (Parent 9) “Well, I think between myself and dad, I would put more trust in what the doctor—he was not very trusting. His family, like they have more holistic methods, osteopathic methods.… I saw how the staff treated us and not only the medical team but nurses on the floor, the social worker—everyone made me feel like I could trust them” (Parent 12)	“But I think having a patient doctor relationship helps a lot when you’re talking about new and experimental things. Because I think, especially when it comes to your kid, you sort of—if you know that your—if you trust that your doctor is sort of cares a lot about your kid, I think that you’d have more, maybe faith that the clinical trial might be the right thing for your child” (Clinician 5) “I’ve had many patients who really, they enrolled because that’s what—because they trust us, and they asked us to prioritize the options. And if we prioritize the trial first, they say yes” (Clinician 11) “Where, if a patient or a patient family does not have full confidence in the medical community, I think they’d be less likely to want to enter a phase three clinical trial, like an up-front treatment” (Clinician 1)	Parents and clinicians thematically converged on trustworthiness as a facilitator. Members of both groups reflected on medical mistrust that may exist among historically marginalized communities; however, most parents described high trust in their oncology teams.
Current format of the informed consent discussion	“They needed the signatures at a certain period of time.… And I just felt like I wasn’t given that ample of time.… And you could just imagine the—first of all, just trying to absorb and trying to process the fact that your child has cancer…. And then having to really get up to speed on all areas of the type of cancer your child has, and try to figure out and understand, okay, is this good, or is this necessary, and things like that. And I just felt like, I’m not gonna be pushed and rushed into a situation like this. If it’s not necessary and it’s not something that he gravely needs, we’re gonna pass on that” (Parent 1) “Because it is so much information to kind of digest. Then you’re getting this plethora of information, it’s kind of overwhelming. So then a follow-up maybe a week or just a few days after to just be like, okay, you’ve gotten this information. You digested it, now what are your questions? But not necessarily me having to reach back out to ask these questions” (Parent 24)	“So there’s a time crunch to that, and they’re being so overwhelmed with so many different materials that it’s sort of trying to give an entire civics lesson in the middle of the January 6th revolt” (Clinician 8) “With an upfront trial, they just had been diagnosed. It’s always crazy to me that within 24 to 48 hours of meeting the family and then learning that their child has cancer, we’re immediately talking about research. And it has to happen so early, because that’s when the decisions get made” (Clinician 10)	Both parents and clinicians thematically converged on the informed consent discussion as a key barrier to clinical trial participation. Specifically, the amount of information required to present to families and time pressure contributed to this perception.
Preference for LOE	“I think that it has been somewhat good because sometimes the interpreters are good and say all the right things…and although sometimes it’s frustrating because they don’t translate what one says. So, since I don’t know a lot of English, that does frustrate me sometimes” (Parent 32) “But I guess I would just start with the interpreters and making sure that people—to make sure that they’re 100 percent able to understand and comprehend the information that’s being given to them” (Parent 9)	“I think it is very suboptimal to not have consents in their foreign—in their language. I honestly—I’m struck by we don’t have more translated consents” (Clinician 12) “I honestly think we don’t do as good of a job with families with limited English proficiency. I mean, of course, we have an interpreter, and during the pandemic, most of those interpreters have been available by phone or iPad and that’s really not as good as having them in the room” (Clinician 6)	Both parents and clinicians thematically converged on LOE and lack of available translated trial materials as a barrier to trial enrollment. Members of both groups varied in their perception of how effective or not effective interpreters were during trial discussions with some positive impressions and some negative impressions.
Trial materials	“Maybe not so much text because a lot of text and reading can be overwhelming. I got a lot of text. I mean I’m a reader, so I read, and I try to—I get a better understanding from reading. But maybe more families would have—like it would be better for families if they have like simplified versions of things or things that had more pictures explaining, like, you know, explaining what would happen so they can visually see” (Parent 12) “So if they can find a way to do it verbally, as well as have some type of imagery, it would help tremendous, because like I said, some people don’t learn just by reading. Some people learn by seeing and hearing” (Parent 2)	“I mean, we don’t have any very basic educational materials about what is a clinical trial and the different types of clinical trials.… I mean, I could see that as being helpful to people to just as a primer on what is a clinical trial” (Clinician 8) “The informed consent documents are a little intimidating I have to say. They’re like 30 pages, a lot of legal talk and it takes us a long time to go through it. It’s just too much information no matter your level of education. So I worry a little bit about more written material, because we already give a lot of written material and I’m not sure how much of it actually gets read as it is” (Clinician 3)	Both parents and clinicians thematically converged on the lack of adequate trial materials as a barrier to trial enrollment. Members of both groups identified this absence made information sharing challenging. Some parents suggested additional visual information, while some clinicians suggested more education regarding clinical trial fundamentals.
Study requirements	“And I just feel like testing what you’re already gonna be doing, as far as samples and stuff like that, I’m all for that” (Parent 1) “A couple of times—I think I may have declined like some of the blood draws because during the time he wasn’t feeling well or he was having a tough time on certain days, so I would decline” (Parent 12)	“So I’ve seen in consult…four or five kids in the New England area who would be eligible for a new drug for being refractory, but the barrier that the family has cited for not enrolling is the need to come to [institution] weekly for X number of weeks” (Clinician 12) “But sometimes we are checking labs more frequently, and things like that, and the families do get billed through their insurance for that” (Clinician 14)	Clinicians perceived study requirements to be a barrier to trial participation due to additional travel and associated costs. Parents expressed more ambivalence about whether study requirements were a barrier. Parents chose to decline extra tests if they might cause extra discomfort to their child or more stress, but this did not influence trial participation overall.
HMH	“Or, you can have a family like mine, where it’s a struggle for everything…. That [extra visits for clinical trial] would be a lot more added to my plate. But then at the same time, if I’m thinking about my child, if this is something that is gonna help him, I’ll find a way. But will it cause more stress?” (Parent 23) “Because I was just like, okay, how are we going to do this financially? But no matter what, we’re going to find a way because the whole thing is about preserving our daughter’s life” (Parent 26) “With him, when we went to the clinic, the ride actually helps a lot, because getting to and from there with cabs and the bus, it’s really hard. But still, it was like, okay, as long as we have this, we can go there no problem” (Parent 2)	“I think just barriers to getting here. It’s a lot of visits if you’re on a trial, especially the first cycle.… And so that can be hard for some families to get here if they don’t have transportation or access to gas, things like that” (Clinician 14) “I’ve definitely had situations and perhaps they are more common with my patients of color that they are dealing with last-minute changes of plans, like a family member gets called into work when that wasn’t expected or transportation issues pop out to me as a consistent barrier, because getting to Boston is a huge pain” (Clinician 10) “Well, I think that some of the socioeconomic challenges are more prevalent in the Black and Latino populations. And so, if we’re talking about those kinds of financial barriers to trial enrollment, I think we have to be sensitive to the fact that those challenges may be more common there” (Clinician 6)	Parents did not explicitly identify HMH as a barrier to trial participation and instead were willing to do whatever was perceived to be necessary for their child’s care, despite additional stress related to HMH. Clinicians explicitly identified HMH as a barrier to trial participation.
Experimental nature of trials	“Well, as a Black culture, I think as—we had—we were test dummies. A lot of things were done to us in the hospitals just to get a better understanding of our race and culture, some we were aware of and some that was just—it was forced upon us. So I mean I think—and especially for me as a Black man, having those things done through—to my ancestors over time, I think that was—when I had first heard about clinical trials, I’m like, no, thank you. But I think with the understanding that it was happening to [my child] and that we needed to gather and get more information, I agreed more so to advance her treatment and her care” (Parent 26) “For me [sighs], clinical trial, I can’t help but think of like experiment, for some reason. Because I mean there’s no—it’s a new—it’s something that’s new and being done to learn about something. So for me, I guess the word would be experiment. That’s what would automatically come to mind. But not like in a bad way; in a good way to learn and hopefully advance in the treatment of whatever’s—whatever they’re trying to learn about” (Parent 12) “I guess you can say a necessary evil.… So essentially it’s a good thing because if we have to understand, you know, how something is or isn’t going to work, but then the evil part being because essentially you have a group of folks being test dummies on something that could be potentially harmful” (Parent 24) “My wife and I are thinking we didn’t wanna put [child]—have him be treated like a guinea pig-type thing. We didn’t want him to have to go through unnecessary treatment if he didn’t have to.… Other research, gathering of information, and going through stool samples, and stuff like that, stuff that he normally goes through, we can provide to you guys.” (Parent 1)	“When I’m talking to Black and Latino families, I more often get the response, I don’t want to do studies” (Clinician 2) “With every consent we say one of the potential risks of being on a clinical trial is lack of privacy, and that your data will be de identified, but your chart will be reviewed by others. I think stories like Henrietta Lacks scares people. And I think in certain communities, maybe there is that more of a distrust of medical, potentially, because of stories like that. And for good reason, because there was stuff like that that happened. So I think we try to say, hey, your privacy is very important. We will do everything we can to protect your privacy, and things like that, to instill trust. But I do think that might be a concern as well” (Clinician 14) “I think some families are worried that their child’s being, what we say, experimented on. We see that less frequently, but definitely do hear it.” (Clinician 11)	While clinicians and parents recognized experimentation as a potential barrier for some, most parents accepted the reality that experimentation was necessary for scientific advancement despite the historical context of maltreatment in their communities or other held beliefs. Most parents did not consider the experimental nature of trials to be a prohibitive barrier.
Representation	“Why did I participate? Because I believed that it was good for you to know, or that you find out, about how to treat people like us who are Hispanic or come from other countries” (Parent 33) “The majority of the research probably involves Caucasians. But I wanted to provide people with like an aspect of—from an African American family because it’s not—there aren’t as many” (Parent 12)	NA	Increasing representation was a unique facilitator identified by 2 parents.
Gatekeeping	NA	“But then we are like, well, they are not a good candidate for trials because they have a poor history of being compliant. I’m sure there’s an interplay there. I’ve never seen people just based on, well, they probably—because of their socioeconomic status, probably not a good candidate. But I’m sure compliance, I think, is the biggest—it could be a surrogate to socioeconomic status” (Clinician 9) “So there are, I think for Black and Latino patients who have resource limitations, for example, transportation or just parents work. So they have more, I can’t come today I have to come tomorrow kind of issues. You are less likely to enter into the conversation about a clinical trial to begin with. And as we know, those resource limitations are more common in Black and Latino families and we probably overestimate them, we maybe assume them more often of Black and Latino families then we do in Caucasian families” (Clinician 2) “And it drives me bananas.… Well, yeah, we’ll just sort of hear, oh, not a ‘good trial candidate’. I think people maybe have a little bit of a different perception of, well, they come to the [clinic] every week and they take their standard of care drug. Why would they not be a reasonable trial candidate?” (Clinician 3)	Gatekeeping was identified as a barrier to clinical trial enrollment by clinicians; often occurring due to perceived distrust of research or perceived issues with adherence (related to HMH). Clinicians varied in how acceptable they viewed this practice.

Abbreviations: HMH, household material hardship; LOE, language other than English; NA, not applicable.

Figure. Parent- and Clinician-Identified Factors Acting as Facilitators and Barriers.

Figure adapted from Manz et al,⁴² 2025.

Parents and clinicians thematically converged on 2 key facilitators: altruism and trustworthiness. Parents and clinicians thematically converged on multiple barriers at the clinician and trial or systems levels, including the informed consent discussion and trial materials, and noted these factors were particularly challenging for families preferring non-English languages. Parents and clinicians thematically diverged regarding HMH and the experimental nature of trials as barriers to participation, with some clinicians emphasizing their effect on parent decision-making while parents did not identify these as decision-making drivers.

Altruism and Trustworthiness

Parents and clinicians identified altruism and trustworthiness as facilitators to clinical trial participation. Both groups thematically converged on the opportunity to advance science for future families as a strong facilitator for clinical trial participation.

Quantitatively, parents reported high trust in their oncology team with a mean (SD) score of 4.65 (0.65) on the Trust in Oncologist scale (5 indicating complete trust). Parents and clinicians qualitatively identified trustworthiness as a key facilitator of clinical trial participation. While parents and clinicians acknowledged that marginalized communities have a history of medical maltreatment and reasons for mistrust, parents did not view this as a prominent factor for decision-making. Many parents attributed the trustworthiness of clinicians to their communication and reputation.

Informed Consent Discussion

Most parents (51 [85%]) reported high confidence filling out medical forms, reported no or occasional problems learning about their child’s medical condition based on written information (45 [75%]), and needed no or occasional help reading hospital materials (42 [70%]). Despite this, the informed consent discussion and associated sense of urgency emerged as a barrier to trial participation. One parent declined trial participation due to limited time to consider participation while processing their child’s diagnosis.

Parents suggested highlighting differences between trials and standard of care and explaining the study phase, accrual numbers, and existing data about trial medications (eg, from other populations and diseases) to improve consent discussions. Nearly all parents asked for more time and suggested breaking the consent discussion into multiple sessions or having a planned encounter to check back in. Despite the overwhelming nature of consent discussions, parents shared that transparent, clear, and honest communication facilitated their decision to participate.

Clinicians also recognized that the informed consent discussion was overwhelming for families, particularly at diagnosis, and worried this limited true informed consent. To mitigate this, clinicians used strategies such as transparent communication with limited medical jargon.

Language Other Than English

Many parents (25 [42%]) preferred a language other than English (LOE). Both parents and clinicians qualitatively noted that information sharing during informed consent discussions was more challenging for these families. Multiple clinicians noted the absence of translated consent materials.

Clinicians and parents had variable interpreter experiences. Some parents found them helpful, and others felt they lacked important context. Some clinicians noted that informed consent discussions were longer with interpreters and suboptimal with remote interpreters.

Trial Materials

Parents and clinicians had suggestions for trial materials, which they felt were a barrier to understanding trials. They focused on the informed consent document and limited educational materials. Multiple parents suggested having information presented in different forms, such as diagrams, visuals, or videos. Clinicians expressed that basic educational materials usable across trials would be helpful.

Study Requirements

Clinician and parent perspectives differed on why and the extent to which study requirements impacted participation. Parents were more ambivalent regarding study requirements. Parent concerns focused on whether additional visits or tests would cause extra pain or discomfort to their child. They were amenable to extra tests on already-collected samples. Few parents viewed extra tests as an opportunity to learn more about their child’s disease and treatment response. Clinicians more uniformly viewed extra visits and tests as barriers for families due to travel and cost.

HMH

Most parents (44 [73%]) quantitatively reported at least 1 domain of HMH, including housing (29 [48%]), food (25 [42%]), utilities (15 [25%]), and transportation (15 [25%]). Despite high prevalence, no parents explicitly identified HMH as a barrier to trial participation. Instead, many parents spoke of their willingness to do anything to ensure that their child received the care that they needed, while concurrently acknowledging HMH-associated stress during cancer care regardless of treatment plan.

In contrast, clinicians characterized HMH and financial burden as a significant barrier to participation and a leading factor contributing to underrepresentation of marginalized populations on clinical trials. While some clinicians acknowledged that there were hospital resources to overcome this barrier, others did not offer trials to families perceived to have HMH due to concerns related to adherence to trial requirements. More information appears later in the “Gatekeeping” section.

Experimental Nature of Trials

Some clinicians perceived that the experimental nature of clinical trials was a particular barrier for historically marginalized parents, including the belief that Black and Hispanic parents do not want their child to be a “guinea pig.” While parents acknowledged apprehension with experimentation—particularly in the historical context of medical maltreatment in their communities—they recognized that experimentation was a “necessary evil” for scientific advancement. A minority of parents meaningfully diverged from this perspective and viewed experimentation as a prohibitive barrier to participation.

Representation

While not widely discussed across parent participants, 2 parents identified representation of their underrepresented communities as a facilitator when asked about motivations for trial participation. No clinician interviews identified this construct.

Gatekeeping

Most clinicians acknowledged that clinical trials were not offered to all medically eligible patients, although they meaningfully diverged in how acceptable they found these practices. Clinician-identified nonmedical factors influencing trial offers included opinions about a family’s willingness to engage or ability to adhere to trial requirements. Concerns regarding adherence were intricately tied to a family’s perceived financial or resource needs. At the same time, some clinicians expressed frustrations at this practice of gatekeeping. Others mentioned gatekeeping practices have decreased over time, with effort instead focused on meeting resource needs. No parent interviews identified this construct.

Discussion

Black and Hispanic parents and pediatric oncology clinicians thematically converged on key facilitators (altruism and trustworthiness) and barriers (informed consent, trial materials, study requirements, and preference for LOE) to trial participation. These findings are consistent with prior data in predominantly White populations.^43,44,45 Importantly, our data highlight that while many clinicians viewed HMH and experimentation in clinical trials as barriers to participation, parent perspectives did not echo this clinician viewpoint.

Despite quantitatively high HMH prevalence in our cohort (>70% reported HMH), parents did not decide on trial participation based on these unmet needs and acted on whatever they perceived to be best for their child. Clinicians, however, viewed HMH as a significant barrier to participation for Black and Hispanic families aligned with prior literature.⁴⁶ This divergence may highlight differences unique to parental decision-making in the context of pediatric cancer. Findings from prior studies focused on decision-making suggest that parents of children with cancer prioritize doing right by their child and may be more willing to sacrifice or accept risk to do so^47,48; this logic may extend to the material hardship that parents are willing to accept. In addition, it may be that the incremental material burden associated with clinical trials compared with the intensive nature of many standard-of-care treatments may not be meaningfully different to families.

Historically, underrepresentation of marginalized populations on clinical trials has been attributed to distrust^46,49,50,51; however, parents quantitatively and qualitatively reported high trust in their oncology teams, suggesting that distrust was not a prominent barrier. Though both parents and clinicians agreed that trustworthiness facilitated trial participation, clinicians felt that distrust was more likely to be a barrier for Black and Hispanic parents due to concerns regarding experimentation. While some parents reflected on the history of medical abuse and maltreatment experienced by their communities, most parents recognized that experimentation was necessary to advance science and were willing to accept this “necessary evil” in the pediatric oncology context. Pediatric oncologists should remain sensitive to this historical context, while also recognizing that Black and Hispanic families have high trust in their oncology teams, are willing to consider trials despite this historical context, and may be additionally motivated to represent their communities in research.⁵²

Despite these parent perspectives, some clinicians acknowledged that gatekeeping occurred when families were perceived to have unmet needs and/or difficulty adhering to trial requirements due to HMH. Other studies in adult oncology have described gatekeeping practices as a barrier to clinical trial enrollment.^53,54 Limiting the offer of a trial based on the perception of a family’s willingness or ability to participate introduces bias, reduces patient and familial autonomy, and hinders equitable trial access.^55,56,57 These data highlight a fundamental principle of clinical trial equity: patients and families can only access trials if offered. Our data align with adult oncology literature demonstrating that if offered, historically marginalized participants often choose to participate.⁵⁸ While clinicians may consider gatekeeping necessary to maintain clinical trial integrity, these findings highlight that interventions focused on maximizing patients and families’ ability to successfully participate in clinical trial are necessary.

These data identify 2 opportunities to improve the clinical trial experience of historically marginalized groups. First, a standardized approach to identifying eligible patients and systematic data monitoring may mitigate clinician-level gatekeeping.⁵⁹ Second, while parents did not perceive HMH to be a barrier to participation, HMH is associated with high parental distress regardless of clinical trial care or standard treatment.^29,60,61 Interventions to increase systematic and longitudinal screening for HMH as a pediatric oncology psychosocial standard of care⁶² may (1) limit clinician assumptions regarding a family’s basic resource needs and (2) identify families in need of augmented financial and resource support at specific inflection points (eg, cancer relapse when considering early phase trial enrollment). Systematic screening and provision of support to address HMH may thereby improve outcomes and reduce clinician gatekeeping.⁶³ Next steps include validating these findings in a broader pediatric oncology population while concurrently improving standardization of trial eligibility screening and resource provision to advance equity.

Limitations

This study has limitations. It was conducted at a single academic center with a national reputation for pediatric cancer care, which may limit broad generalizability of these findings and may have influenced findings regarding high parent trust. This analysis focused on barriers and facilitators to clinical trial participation after families had already accessed care at a site offering frontline and early-phase trials and thus may not identify barriers to accessing centers. Eligible parents were identified using EMR-reported child race and ethnicity, which may have missed eligible participants. Clinicians and parents received modest remuneration via gift cards for participation, which may have led to desirability bias. Participants in our study may be at risk of sampling bias and could be more likely to view research participation favorably; however, this is likely mitigated by our 94% parent participation rate. Future studies could strengthen comprehensive understanding of barriers and facilitators by applying a formal framework to the qualitative analysis and including additional sites and populations (including patients, psychosocial clinicians, and clinical research teams) for further triangulation.

Conclusions

In this cross-sectional study of parents of Black and Hispanic children with cancer and clinicians, parents expressed high trust and a willingness to accept experimentation in the pediatric oncology context, and they were motivated to participate in trials if offered. While clinicians in our study identified HMH and distrust of experimentation as prominent barriers to trial participation for marginalized groups aligned with prior literature, our parent data challenge this viewpoint. Next steps to improve equitable clinical trial participation include reducing clinician gatekeeping practices based on these perceptions through interventions focused on standardized trial eligibility screening and identifying and reducing HMH.

Supplement 1.

eAppendix 1. Survey Domains and References

eAppendix 2. Survey

eAppendix 3. Parent Interview Guide

eAppendix 4. Clinician Interview Guide

Supplement 2.

Data Sharing Statement