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Turning Patient Access into Participation: What’s Still Missing in Clinical Trials
Decentralized clinical trials have expanded access—but access alone doesn’t fill studies.
The missing link isn’t reach. It’s participation.
And reach is where it starts.
Too often, DCTs are treated as a silver bullet for enrollment and retention. But while they remove logistical barriers, they don’t automatically drive engagement. Access may open the door—but it doesn’t ensure patients walk through it or stay.¹
To truly improve enrollment and retention, trials must be designed not just for access, but for participation. That means treating protocols and participants as equally important variables from the very beginning.
Start with the Protocol—Not the Technology
Participation is shaped long before a patient is enrolled—it begins with protocol design.
The critical question: what truly requires a site visit?
Consider:
- Routine health checks
- Procedures that don’t require specialized equipment
- Drug administration
- Monitoring
The answer is rarely binary. While some activities can be fully decentralized, most trials benefit from a thoughtful mix of on-site and remote elements.¹
Engaging a DCT partner early in protocol development helps identify what can—and should—be decentralized. More importantly, it ensures the right tools are used in the right way to reduce burden across the entire participant ecosystem, including caregivers and families.
Because the reality hasn’t changed: site visits remain one of the biggest drivers of participant burden. Travel time, cost, and disruption to daily life still influence whether someone enrolls—or drops out before they begin.³ ⁴
Reducing unnecessary visits doesn’t just improve convenience. It removes friction before participation even starts.
Access Doesn’t Mean Fit
Expanding access is essential. It’s how clinical trials reach more patients, reduce barriers, and create more equitable opportunities to participate.¹ ²
But access alone doesn’t guarantee engagement.
One of the biggest mistakes in DCT adoption is assuming that more access automatically leads to better participation.
It doesn’t.
Because participation isn’t one-dimensional—and neither are the tools designed to support it. What improves access for one patient can introduce new challenges for another:
- Home visits
A meaningful convenience for some. For others, they can feel intrusive or misaligned with personal or cultural preferences.² ⁵
- Digital and telehealth solutions
Powerful enablers of access—when patients have the devices, connectivity, and digital confidence to use them.⁶ ⁷
- Expanded or community-based sites
Bringing trials closer to patients is critical—but proximity alone doesn’t account for privacy concerns, cultural context, or individual comfort.² ³
These approaches are valuable—but only when applied thoughtfully.
That’s why offering participants a choice of options isn’t just beneficial—it’s essential.
Because the goal isn’t just to expand access. It’s to deliver access in a way that fits into real lives—creating an experience people are both willing and able to engage with.
Bridging the Gap: Flexibility, Choice, and Support
Closing the gap between access and participation requires more than offering options—it requires designing for flexibility from the start.
Hybrid trial models—the intentional blend of on-site and remote elements—allow sponsors to balance protocol requirements with real-world patient needs.¹
But flexibility alone isn’t enough.
Support is what turns options into action.
Concierge services, such as patient navigators, play a critical role in guiding participants through the clinical journey. They help patients and caregivers:
- Understand their choices
- Navigate logistics
- Overcome barriers in real time
In doing so, they translate protocol into lived experience—reducing uncertainty, easing burden, and improving engagement for both participants and site teams.¹
Designing for Participation, Not Just Access
The industry has made meaningful progress in expanding access to clinical trials.
But access alone was never the end goal.
What’s still missing is intentional design—trials built around flexibility, choice, and support. Trials that don’t just introduce more tools, but apply the right tools for the people they’re meant to serve.
Hybrid approaches succeed not because they decentralize more—but because they align better.
Because expanding reach is only the beginning—
real success comes from turning that reach into meaningful participation.
References
- Kijewski S, et al. “Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges.” PLOS Digit Health. 2026. https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0001191 Last Accessed June 2026.
- Vayena E, et al. “Decentralised clinical trials: ethical opportunities and challenges.” Lancet Digit Health. 2023. https://www.thelancet.com/journals/landig/article/PIIS2589-7500%2823%2900052-3/fulltext Last Accessed June 2026.
- Society for Clinical Research Sites. “Reducing patient burden in clinical trials: strategies for improved retention.” 2024. https://myscrs.org/resources/reducing-patient-burden-in-clinical-trials-strategies-for-improved-retention/ Last Accessed June 2026.
- Borno HT, et al. “At what cost to clinical trial enrollment?” Oncologist. 2018. https://academic.oup.com/oncolo/article/23/10/1242/6439749 Last Accessed June 2026.
- van Rijssel TI, et al. “The ethics of decentralized clinical trials and informed consent.” Health Care Anal. 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC12052907/ Last Accessed June 2026.
- Arias López MP, et al. “Digital literacy as a new determinant of health: A scoping review.” PLOS Digit Health. 2023.
- Goodson N, et al. “Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion.” NPJ Digit Med. 2022. https://www.nature.com/articles/s41746-022-00603-y Last Accessed June 2026.