The scale of the undertaking is itself remarkable. The research team, led by Sarah Scruton and colleagues affiliated with the Marathon of Hope Cancer Centres Network Patient Voices Initiative, searched five databases spanning Ovid MEDLINE, PubMed, Scopus, CINAHL Complete and Web of Science, retrieving 7,918 candidate studies. After rigorous screening calibrated with statistical agreement measures, 131 studies published between 1979 and 2026 met their criteria. Roughly half were conducted in the United States, with the remainder scattered across the United Kingdom, Canada, Australia, China, Denmark, South Korea and beyond. Most focused exclusively on patients rather than caregivers, and more than half included participants who had declined or never been offered a trial, giving the review a rare window into the minds of the hesitant rather than only the committed.

The dominant barrier, reported in all but five of the included studies, was psychosocial. Fear in its many forms topped the list: fear of side effects from experimental treatments appeared in nearly 62 percent of studies, fear of being experimented on, the so-called guinea pig phenomenon, in just under 52 percent, and fear of randomization in about 41 percent. The dread of receiving a placebo or sugar pill was specifically voiced in 22 studies. In one breast cancer cohort, 44.7 percent of women who declined a trial said random assignment would discourage them, compared with just 12.4 percent of those who accepted. Among adolescent and young adult patients, qualitative work revealed a deeper anxiety: the fear of decisional regret if randomization assigned them to an inferior treatment arm, with parents shouldering the blame.

Distrust emerged as a second psychosocial pillar, reported in 37.4 percent of studies. Participants questioned whether research served their interests or those of physicians, pharmaceutical companies and career-minded investigators. In a Danish study, 34 percent of trial participants and 23 percent of non-participants agreed that medical research primarily promotes doctors’ careers. More strikingly, 17 studies documented distrust rooted in historical abuse, particularly among Black and Hispanic participants and older adults, with the Tuskegee Syphilis Study cited explicitly as a touchstone of medical betrayal. This legacy of racism in medicine continues to shape willingness to enroll, a finding the authors argue demands relationship-building and transparency rather than simple reassurance.

Logistical burdens formed the second major theme, raised in 73.3 percent of studies. Travel to trial sites, out-of-pocket costs, extra hospital visits and tests, time off work, and strain on family members all weighed heavily. In one Australian survey, 54 percent of patients said they would not join a trial if any out-of-pocket costs were involved, and 57 percent said they would refuse if it required changing oncologists. Among older adults, 82.7 percent identified needing care from family or friends as a barrier. Caregivers described relocating to be closer to cancer centers and absorbing the scheduling demands of appointments, yet fewer than 10 percent of the included studies captured their perspectives at all, a gap the review identifies as significant given caregivers’ central role in transportation, medication adherence and decision-making support.

Informational barriers, reported in 68.7 percent of studies, proved equally pervasive. Patients frequently did not know relevant trials existed, with 12 studies reporting that physicians never discussed trials as an option. Those who searched on their own found the process confusing and overwhelming; in one UK study of patients with secondary breast cancer, 53 percent of those who consulted a trial registry could not find the information they needed. Misconceptions about trial purpose and randomization were widespread, with one study reporting that 94.2 percent of trial refusers lacked understanding of the trial’s goal. Consent forms were described as lengthy, complex and intimidating, and language barriers compounded the problem for Asian American and Hispanic patients, one of whom ranked language as the second-highest obstacle to participation.

The interplay between fear and information emerged as perhaps the review’s most consequential insight. The authors note that fear-based and informational barriers often co-occurred, suggesting that limited understanding may fuel anxiety about experimental treatments, and that health literacy may explain the relationship, since trial awareness and participation are consistently higher among more educated individuals. If fears stem from missing or muddled information, they may be mitigated by clear, accessible communication, a hypothesis supported by prior evidence that web-based education programs, decision aids and simplified consent materials improve knowledge and foster more positive attitudes toward participation across health literacy levels.

Patients themselves offered a roadmap for improvement. Clear, credible and accessible information was the most commonly recommended facilitator, cited in 42 percent of studies, including plain-language consent forms, multiple information formats and centralized trial databases. Building trust came second, with participants emphasizing conversations with knowledgeable, respectful providers, and for racialized groups, research teams that share their ethnicity. Logistical supports ranked third: expense reimbursement, transportation and lodging, childcare, telehealth options and flexible scheduling. Some participants suggested trial designs granting more autonomy, and others called for mental health, spiritual or peer support during participation.

The review’s limitations are acknowledged candidly. Most studies did not specify trial phase or intervention type, limiting conclusions about which barriers dominate in early-phase versus late-phase research. Nearly half the literature is American, raising questions about transferability to other healthcare systems. Few studies compared barriers across racial or ethnic groups despite documented disparities in trial access, and none systematically examined how geography, income or education shape participation decisions. The authors also note that their review, consistent with scoping methodology, mapped the evidence rather than appraising its methodological quality.

Nevertheless, the synthesis arrives with clear implications. Structural solutions already exist in pockets: Canada’s ULink and Hope Air programs assist with travel and lodging, the Canadian Remote Access Framework for Clinical Trials guides delivery to rural patients through satellite centers, and Australia’s Tele-Trial Model brings trial procedures closer to home. What the review adds is the patient’s own voice, systematically assembled, arguing that recruitment will not improve through persuasion alone but through redesigned trials that respect fear, honor distrust, lighten logistical loads and speak plainly. As precision oncology expands the menu of targeted therapies, the bottleneck may no longer be scientific discovery but the human architecture of participation itself.

Subject of Research: Barriers to cancer clinical trial participation reported by patients and caregivers

Article Title: Patient and Caregiver Reported Barriers to Cancer Clinical Trial Participation: A Scoping Review

Article References: Scruton, S., Ito, C., Bohnen, J., Urquhart, R., Hessels, C., Konechny, S., Kraft, R., Thompson, R., Ho, C., Weymann, D., Bombard, Y., Krebs, E., Denburg, A., Hanna, T. P., Lim, H. J., Shareen, S., Regier, D. A., & Pollard, S. (2026). Patient and Caregiver Reported Barriers to Cancer Clinical Trial Participation: A Scoping Review. Cancer Reports, 9(10), Article e70700. https://doi.org/10.1002/cnr2.70700

Image Credits: AI Generated

DOI: 10.1002/cnr2.70700

Keywords: cancer clinical trials, patient barriers, caregivers, scoping review, psychosocial barriers, distrust in medicine, health literacy, informed consent, precision oncology, trial recruitment, health equity, logistical barriers

The authors, led by researchers including Lesli E. Skolarus, point to a familiar litany of failures. Many stroke trials finish later than expected, inflating costs and delaying scientific progress. When enrollment targets are missed, the resulting loss of statistical power can render years of work inconclusive. Trials may also produce results with limited applicability to routine practice, for example when participants do not receive all standard-of-care treatments such as endovascular therapy. And even practice-changing findings can languish: the limited adoption of dual antiplatelet therapy for high-risk transient ischemic attack and minor stroke demonstrates how slowly evidence can translate into care. These challenges, the authors argue, demand approaches that improve trial efficiency, enhance clinical relevance, and accelerate translation into real-world practice.

The central insight of the framework is deceptively simple. A clinical trial is not merely a test of a treatment; it is an intervention that must be adopted by trial sites, integrated into clinical workflows, embraced by patients and caregivers, and coordinated across health systems. Viewed this way, every trial is an implementation problem. Community engagement helps ensure that trials address clinically meaningful questions aligned with the needs and priorities of affected constituents, while implementation science offers structured methods to identify multilevel determinants of success and to select strategies that support trial feasibility, conduct, and eventual translation. Evidence from outside stroke, particularly from COVID-19 vaccine trials and public vaccination rollouts, suggests that pairing community engagement with implementation science can improve trial efficiency, quality, and relevance.

The framework unfolds across four phases, beginning with community partnership. The first task is identifying which partners are needed and determining the optimal level of engagement. Potential constituents span a remarkably wide range: stroke survivors and caregivers, patient advocacy organizations, site principal investigators and clinical teams, healthcare organizations, community-based organizations, employers and government agencies as purchasers, insurers as payers, policymakers, and drug and device manufacturers. The right mix depends on the trial’s objectives and setting. An acute stroke trial might partner with emergency medical services and emergency departments for recruitment, a clinical trial network for conduct, and hospital administrators or payers to address feasibility, reimbursement, and downstream adoption. A recovery trial for chronic stroke survivors, by contrast, might recruit through community organizations, co-develop the intervention with occupational therapists, and engage local government or insurers to sustain the intervention in community settings.

The level of engagement matters as much as the roster of partners. The authors envision most stroke trials benefiting from either consultation or sustained involvement. In the consultation model, constituents provide input at defined stages through focus groups, trial design studios, and, for trials conducted under an exception from informed consent, community consultation and public disclosure. Consultation suits acute stroke trials, where narrow eligibility windows, protocol-driven care, and emergency consent exceptions leave little room for deeper involvement. Prevention and recovery trials, with longer horizons, may instead sustain a community advisory board that influences the trial across its entire lifecycle. Studies co-led by constituents appear more frequently in hybrid effectiveness-implementation research, such as efforts to increase acute stroke treatment rates in underserved communities.

The second phase embeds these perspectives into trial conception and design. Community partners can shape the research question so that it reflects the priorities that matter most to patients, caregivers, and communities, and can inform feasibility, acceptability, and equity considerations from the outset. The research team can then apply implementation science frameworks prospectively, most notably the Consolidated Framework for Implementation Research, or CFIR, which organizes anticipated determinants across intervention characteristics, inner and outer settings, individual characteristics, and implementation processes. Prior efforts to address trial barriers have focused mostly on participant-related issues. The CFIR deliberately broadens that view, prompting systematic evaluation of site-level, organizational, and system-level obstacles alongside participant concerns.

This early assessment surfaces the contextual frictions that so often derail stroke trials: transportation constraints, caregiver burden, workflow pressures in emergency departments, reimbursement worries, and health-related social risks that shape whether survivors can participate and whether sites will adopt a study. Naming these barriers exposes the inevitable trade-offs in trial design, where many decisions lack a single right answer yet directly affect participant experience, feasibility, cost, and future adoption. Trialists may prefer longer, more frequent in-person outcome assessments to capture exploratory endpoints, while participants facing transportation barriers may prioritize shorter, remote assessments. Teams may design higher-intensity interventions to maximize efficacy, while health systems and payers favor simpler, lower-cost approaches that integrate readily into routine care. By surfacing these tensions during conception and design, the framework lets trialists navigate them transparently and refine protocols against real-world constraints.

The third phase carries the approach into trial conduct, supporting efficient rollout and ongoing adaptation. Brief interviews, workflow mapping, surveys, and data review during launch and early enrollment allow teams to identify emerging barriers across CFIR domains. In partnership with engaged constituents, those determinants are then mapped to evidence-based implementation strategies. If enrollment is limited by emergency department workflow pressures, the response might include identifying site champions, redesigning workflows, or restructuring care so that study introduction is embedded in routine clinical practice with a handoff to the research team. If retention suffers from caregiver burden or transportation challenges, remote assessments or flexible scheduling may be warranted. This iterative loop strengthens efficiency while keeping the trial aligned with constituent priorities.

The fourth phase extends engagement into interpretation, dissemination, and translation. Implementation science broadens evaluation beyond efficacy endpoints to include implementation outcomes such as penetration and sustainability, fidelity to trial procedures, feasibility of meeting enrollment goals, and timeliness of completion. Engaged constituents can contextualize results and shape dissemination strategies for audiences as varied as stroke survivors with cognitive, language, or activity limitations, caregivers, clinicians, administrators, and policymakers. Early involvement of payers, healthcare organizations, and policymakers can smooth the path to reimbursement and sustainability if findings change practice. Once efficacy and safety are established, hybrid effectiveness-implementation designs allow clinical outcomes and implementation strategies to be evaluated simultaneously, accelerating adoption, an approach already used in stroke primary prevention and acute treatment and emerging in posthospital stroke services.

The authors are candid about the limitations. Sustaining constituent engagement requires resources that are often scarce, and tokenistic engagement, in which feedback is solicited but never incorporated, remains a real risk. There is also limited evidence comparing the effectiveness of different engagement levels; rigorous evaluation would require randomizing trials to distinct engagement strategies. Still, the framework offers a coherent answer to a stubborn problem: by aligning trial design and conduct with the needs of the people affected by stroke, and by deploying implementation strategies against multilevel barriers, stroke trials could become faster, more relevant, and far more likely to change practice, advancing stroke health for all.

Subject of Research: Integrating community engagement and implementation science into stroke clinical trials

Article Title: Advancing Stroke Clinical Trials Using Community Engagement and Implementation Science Approaches

Article References: Skolarus, L. E., Brown, D. L., & Boden‐Albala, B. (2026). Advancing Stroke Clinical Trials Using Community Engagement and Implementation Science Approaches. Annals of Clinical and Translational Neurology, 13(10), 2148-2153. https://doi.org/10.1002/acn3.70461

Image Credits: AI Generated

DOI: 10.1002/acn3.70461

Keywords: stroke, clinical trials, community engagement, implementation science, CFIR, trial recruitment, patient engagement, hybrid effectiveness-implementation designs, translational research, health equity, stroke prevention, dissemination