Clinical Trial Participation: How Can We Make it More Feasible?
Our industry has been asking the wrong question for far too long. “Why don’t more patients participate in clinical trials?” appears everywhere, from conference panels to executive strategy discussions and industry white papers. This may sound like the right place to begin, but it carries an assumption that doesn’t hold up under close scrutiny. It assumes that participation is primarily driven by willingness, as though patients need to be persuaded, educated, or convinced of the value of research.
That framing doesn’t reflect reality. The core issue isn’t willingness; it’s feasibility.
When you step outside the system and listen closely to patients—not just through survey data, but through lived experience as well—you begin to hear a vastly different story. Patients aren’t sitting on the sidelines because they lack interest or motivation. Instead, they’re standing at the edge of a system that often doesn’t align with the realities of their daily lives.
This distinction is foundational. Misinterpreting the problem leads to inevitably designing the wrong solutions. The industry invests in awareness campaigns when the true barrier is access. We refine recruitment messaging while leaving the underlying patient experience unchanged. We celebrate innovation at the margins while preserving systems that remain fundamentally difficult to navigate.
Not only the data, but the lived experience also reflects this misalignment. Participation in cancer clinical trials remains persistently low, with a 2024 national analysis estimating that only 7.1% of patients enroll in treatment trials, and participation is even lower in community settings compared to major academic centers.¹ This isn’t a marginal gap that can be explained by lack of awareness; It’s a systemic issue that demands a different lens.
If we’re serious about improving access, accelerating recruitment, and generating more representative evidence, we must design for feasibility.
Time Isn’t Neutral; It Carries Real Weight
One of the most underestimated burdens in clinical research is time—particularly in the life of a patient navigating illness.
Participation in traditional, site-based trials often requires repeated visits, extended time at clinical sites, travel, waiting, and ongoing coordination with work schedules, family responsibilities, and caregiving obligations. Each of these demands may be manageable individually, yet their cumulative effect can be overwhelming.
Patients experience this as a form of time toxicity—a concept that captures the trade-offs required to participate. Time spent traveling to and from a site is time taken away from work, income, family, and recovery. It’s also physical and emotional energy spent navigating logistics rather than focusing on health.
At a certain point, the burden becomes unsustainable. Patients don’t disengage because they’re unwilling to participate, but rather because participation doesn’t fit within the constraints of their lives.
Regulatory bodies are beginning to recognize this reality. The FDA’s guidance on decentralized clinical trials highlights the role of telehealth, home visits, and local providers in reducing travel and making participation more accessible while improving recruitment and retention.³ This shift signals a broader understanding that trial design isn’t separate from patient experience; it defines it.
The Financial Equation Patients Can’t Ignore
Time burden is deeply intertwined with financial burden, and together they shape the feasibility of participation.
Even when investigational treatments are covered, patients frequently incur indirect costs, including transportation, lodging, meals, childcare, and lost wages. These expenses accumulate quickly and often disproportionately affect those who are already managing financial strain.
Patients are acutely aware of these trade-offs. In a nationally representative study, more than half of respondents indicated that cost-related considerations would strongly influence their decision to participate in a clinical trial.⁴ This finding underscores the reality that participation decisions are made within the context of financial stability and competing priorities.
If clinical trial participation requires patients to absorb financial risk, then access is inherently inequitable. Financial neutrality should be seen as a baseline requirement for inclusive research, as opposed to an aspirational goal.
Protocol Complexity and the Sustainability Challenge
Clinical trials have become more sophisticated and complex, often increasing the burden placed on participants. Recent research demonstrates that patient burden in phase II and III trials has steadily increased, driven by additional procedures, expanded data collection, and longer visit durations.⁵ Earlier studies have shown that as this burden rises, recruitment and retention outcomes tend to decline.⁶
This creates a critical disconnect between eligibility and sustainability. Clinical trials are often designed to determine who can qualify, but far less attention is given to whether patients can realistically sustain participation over time. The result is a system in which patients may be able to enroll, but not necessarily able to remain engaged through the duration of the study.
When patients withdraw, it’s rarely due to lack of commitment. More often, it reflects a protocol that exceeds what’s feasible within the context of real life.
Operational Friction and the Patient Experience
Beyond structural and financial barriers, the day-to-day experience of participating in a clinical trial often introduces additional friction.
Patients frequently encounter challenges related to scheduling, repetitive administrative processes, inconsistent communication, and limited visibility into next steps. While these issues may appear minor on their own, their cumulative effect can erode trust and create a sense of fatigue.
Evidence from CISCRP highlights that logistical challenges remain among the most burdensome aspects of trial participation, while tools that improve communication and coordination are highly valued by patients.⁷ This reflects a broader shift in expectations, as patients increasingly compare their clinical trial experience to the seamless, integrated experiences they encounter in other aspects of life.
When clinical trials fall short of these expectations, the gap becomes both noticeable and consequential.
Equity as a Design Imperative
Feasibility can’t be fully addressed without confronting the issue of equity.
Research consistently demonstrates that underrepresentation in clinical trials is driven by barriers such as transportation challenges, competing responsibilities, language access, and historical mistrust, rather than lack of interest.² Additionally, differences in site-level practices—such as offering flexible hours or financial support—can significantly influence access for socioeconomically disadvantaged populations.⁸ These factors are central to determining who can participate and who can’t.
If these realities aren’t addressed at the design stage, they persist throughout the trial lifecycle, shaping both participation and outcomes.
Reframing the Question
The future of clinical research depends on our ability to ask a better question. Rather than focusing on why patients aren’t participating, we must ask whether participation has been designed to be feasible.
This requires a shift in both mindset and practice. It means embedding patient perspectives early in protocol development, reducing unnecessary burden, simplifying processes, and aligning trial design with the realities of patients’ lives.
It also requires acknowledging that feasibility can’t be a secondary consideration; it’s central to the success of clinical research.
A Moment of Opportunity
This is a pivotal moment in the evolution of clinical research. Advances in decentralized models, digital tools, and data-driven insights offer unprecedented opportunities to reimagine how trials are conducted.
But innovation alone isn’t sufficient. If new technologies are layered onto systems that remain fundamentally misaligned with patient reality, the outcomes will remain unchanged. Recruitment challenges will persist, retention will remain fragile, and disparities in access will continue.
It’s time to realign. When we design clinical trials that fit into patients’ lives, we unlock meaningful progress. Recruitment improves, retention strengthens, and data becomes more representative of the populations we aim to serve. Achieving this requires intentionality, collaboration, and a willingness to challenge long-standing assumptions.
Ultimately, the most important question is not whether patients are willing to participate; it’s whether the industry has created a system in which they can. That’s the standard to meet—and it’s well within reach.
Learn how patient insights are being integrated directly into product and protocol development.
References
- Unger JM, Shulman LN, Facktor MA, Nelson H, Fleury ME. National estimates of the participation of patients with cancer in clinical research studies based on Commission on Cancer accreditation data. J Clin Oncol. 2024;42(18):2139-2148. doi:10.1200/JCO.23.01030
- Heffernan ME, Barrera L, Guzman ZR, et al. Barriers and facilitators to recruitment of underrepresented research participants: perspectives of clinical research coordinators. J Clin Transl Sci. 2023;7(1):e193. doi:10.1017/cts.2023.611
- US Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements: Guidance for Industry, Investigators, and Other Interested Parties. Published September 2024. Accessed March 24, 2026. https://www.fda.gov/media/167696/download
- Williams CP, Geiger AM, Norton WE, et al. Influence of cost-related considerations on clinical trial participation: results from the Health Information National Trends Survey. J Gen Intern Med. 2023;38(5):1200-1206. doi:10.1007/s11606-022-07801-0
- Dirks A, et al. Trends in the burden for patients participating in industry-funded clinical trials. Ther Innov Regul Sci. 2025;59(5):893-900. doi:10.1007/s43441-025-00805-y
- Getz KA, Sethuraman V, Rine J, Pena Y, Ramanath S, Stergiopoulos S. Assessing patient participation burden based on protocol design characteristics. Ther Innov Regul Sci. 2020;54(3):598-604. doi:10.1007/s43441-019-00092-4
- Center for Information and Study on Clinical Research Participation. 2023 Perceptions and Insights Study: Participation Experience. Published 2023. Accessed March 24, 2026. https://www.ciscrp.org
- Florez MI, Botto E, Kim JY. Mapping strategies for reaching socioeconomically disadvantaged populations in clinical trials. JAMA Netw Open. 2024;7(6):e2413962. doi:10.1001/jamanetworkopen.2024.13962
Contact Us
