By Jen Otto, Executive Vice President, Clinical Development, and Erin Farris, Vice President, Operations at Evestia Clinical.
Clinical trial feasibility is the process of evaluating whether a specific clinical program or trial can be successfully conducted in a given geographic region, with the goal of optimizing project completion in terms of timelines, targets, and costs. In rare diseases, feasibility planning presents unique challenges: patients are often dispersed globally, populations are small, and financial and logistical demands are high. Traditional approaches such as manual data gathering, extended site identification, and lengthy contracting can struggle to keep pace with the urgency that patients experience.
Artificial intelligence (AI)-enhanced feasibility tools are transforming the planning and execution of rare disease trials. By accelerating data collection, mapping the patient journey, and providing families with actionable insights, these tools improve trial accessibility and ensure studies are better aligned with patients’ most urgent needs.
Centering the patient in rare disease feasibility
In rare disease trials, the “hard-to-reach patient” is the reality. Successfully identifying and enrolling these individuals requires more than strategic site selection, it demands empathy, creativity, and a holistic understanding of patient needs. Patients rarely navigate this journey alone; families, caregivers, and advocacy communities play essential roles in supporting participation and ensuring trials succeed.
That means feasibility must account for more than protocol fit. It must consider whether families can afford to travel, how children can be supported during long treatment days, and what additional resources can make participation easier. Even a technically sound protocol can fail if it overlooks these realities, leading to under-enrollment or high dropout rates.
Early-phase clinical trials lay the foundation for long-term success, but the stakes are high. Navigating these uncertainties with precision requires not just the right tools, but the experience to interpret and act on them. AI can make this process more efficient, but its true value emerges only when paired with human intelligence, expertise, and empathy.
AI as a force multiplier
At its core, feasibility planning is about information. Knowing where patients are, which investigators have the right expertise, and what barriers might hinder participation is essential. Gathering these insights manually can take weeks or months. However, AI tools can dramatically shorten this process by rapidly scanning trial registries, scientific publications, pipeline reports, and even less traditional sources such as advocacy networks or social platforms.
The real value of AI comes when this data is transformed into insights that directly benefit patients. AI can help identify overlooked trial opportunities closer to home, flag competing studies that may siphon enrollment, or even highlight therapies being repurposed for rare indications. This intelligence helps ensure patients have more and better options to consider.
Although AI can surface opportunities, it takes human expertise to frame the right questions and translate them into effective prompts, interpret outputs, and align findings with patient realities. Smart solutions start with the right people. When technology and experience work together, feasibility planning shifts from guesswork to precision.
Empowering patients and families with knowledge
One of the most profound impacts of AI is increased patient empowerment. In rare disease communities, patients and families are already highly engaged, often scouring global resources to find trial opportunities. AI helps streamline this search, transforming complex trial data into clear, actionable insights.
This changes the relationship between patients and investigators. Rare disease patients often already know which trials interest them, which sites are running them, and how eligibility criteria may apply. However, with AI, they can also compare trial logistics, side effect profiles, and treatment burdens in advance, enabling them to make informed decisions with greater confidence.
When patients arrive at sites better informed, they can make quicker, more confident decisions. This supports both recruitment and retention as participants are less likely to withdraw when they understand expectations early. For families managing chronic conditions or caring for children, this knowledge helps them balance trial participation with other life demands.
By being agile and personalized, AI allows feasibility planning to align with individual patient journeys, while experienced teams ensure that adaptability never compromises safety, compliance, or compassion.
Benefits for smaller sponsors
The stakes are particularly high for small and mid-size biotechs. Every feasibility decision carries weight, shaping both timelines and financial sustainability. AI-enhanced feasibility helps reduce uncertainty by providing fast, data-driven assessments of where and how to run studies.
While Phase 1 trials often rely on known centers, later stages demand broader geographic reach and diverse patient access. Here, AI can guide sponsors toward the right mix of regions, sites, and patient communities, enabling them to compete more effectively and accelerate the development of urgently needed therapies.
By surfacing risks and opportunities earlier, AI also strengthens conversations with investors and partners. A biotech that can demonstrate evidence-based feasibility plans is better positioned to secure funding and strategic alliances. In a space where every month lost means more patients waiting, this can be decisive.
Addressing challenges directly
Like any tool, AI must be implemented in a careful and considered way. Poor-quality data or vague prompts can produce unhelpful results. Protecting confidentiality and aligning with regulatory requirements remain paramount, particularly when patient trust is at stake. While AI reduces manual burden, it does not replace human oversight. Patients still need advocates who can interpret data through the lens of their lived experiences.
Sponsors must also remain realistic; AI cannot solve every bottleneck. Site start-up delays, staffing shortages, and protracted contracting processes remain beyond its control. However, by reaching these stages faster with clearer insights, AI helps ensure that the time sponsors and sites spend is better invested in solving problems that matter most to patients.
Rather than eliminating roles, AI can shift the focus. By implementing AI effectively, feasibility specialists can spend less time combing through spreadsheets and more time designing strategies that directly address patient pain points. This approach can help to reduce travel burdens, anticipate retention risks, and ensure protocols are written in ways that appeal to the people who ultimately make participation decisions.
The future of feasibility
The next five years will likely see AI embedded into feasibility as standard practice, much as risk-based monitoring has become an industry norm. Tools will become more predictive, not only showing where trials can succeed but also analyzing why past studies fell short. This will help sponsors design smarter, more patient-friendly clinical trials from the start, avoiding pitfalls that cost both time and patient trust.
The horizon also points to greater personalization. Future AI systems may allow side-by-side comparisons of multiple therapies, presenting families with simplified tables of risks, benefits, and site locations. With this information, patients could make decisions that feel both clinically sound and personally manageable.
However, not every barrier can be solved with technology. Contracting, staffing, and administrative processes still require human collaboration and alignment. Industry-wide efforts to streamline these steps will be essential to realizing the full promise of AI-enhanced feasibility.
By making rare disease trials easier to find, understand, and join, AI-enhanced feasibility helps ensure that individuals living with rare and debilitating conditions, no matter where they are, have a fairer chance to access potentially life-changing therapies.
This article was contributed by Jen Otto, Executive Vice President, Clinical Development, and Erin Farris, Vice President, Operations at Evestia Clinical.
