Can Smarter Criteria Design Rescue Stalled Clinical Trials?

Healthcare Innovators,

Recruitment remains one of the biggest barriers to successful clinical trials. Despite advances in trial design and technology, the numbers speak for themselves:

• Over 80% of clinical trials fail to enroll participants on time
• 55% of global trials report termination due to low accrual rates
• In the U.S., only 40% of Phase 3 trials achieve enrollment success
• On average, there's a 30% participant attrition rate even in completed trials

What's Going Wrong?

A major culprit is inadequate or poorly designed eligibility criteria. When the criteria are too restrictive, recruitment slows down or fails entirely. When criteria are too broad, you risk introducing heterogeneity that dilutes results and includes participants who may face safety risks due to comorbidities or contraindications.

The real challenge? Balancing feasibility, safety, and generalizability is difficult but necessary! Your eligibility criteria must do more than protect the study's internal validity. They should ensure timely recruitment, reflect the real-world patient population who will ultimately benefit from the intervention, and avoid unintended exclusion of key subgroups (e.g., older adults, minorities, or those with mild comorbidities). In essence, your study cohort needs to reflect reality, not an idealized version of it.

Smart Criteria Simulation

What if we fix the eligibility criteria upfront, before the protocol is even finalized? At Enclavia, we're building tools to help clinical researchers design smarter, safer, and more inclusive trials, before a single patient is enrolled.

Our Inclusion/Exclusion Simulation Engine allows you to model real-world patient data (from EHRs, historical studies, or trial registries) to:

• Simulate recruitment feasibility under different criteria combinations
• Identify how changes in eligibility affect subpopulation representation (e.g., age, comorbidities, gender, race)
• Reduce protocol amendments and recruitment delays through proactive design adjustments

Protocol Feasibility Shouldn't be a Gamble!

With AI-powered simulation, your team can design trials that are: More inclusive, Scientifically rigorous, And faster to recruit.

Until then,
Team Enclavia