Top 5 Clinical Trial Enrollment Metrics to Watch in 2026

Why 2026 Will Redefine Clinical Trial Enrollment

Clinical trial enrollment is entering a new era. As we move into 2026, sponsors, regulators, and patients expect more than just filled studies—they demand speed, accuracy, inclusivity, and efficiency. Traditional measures like “patients enrolled” are no longer enough. The future of clinical research will be defined by metrics that demonstrate real-world readiness, site performance, and regulatory compliance.

Here are the five enrollment metrics that matter most in 2026—and how sites and sponsors can align with them.

1. Time to First Patient In (FPI) as the Ultimate Startup Benchmark

Every day of delay costs sponsors millions and slows access to therapies. Across both the U.S. and Europe, slow patient recruitment remains the single biggest cause of trial delays, accounting for up to 30% of the clinical timeline.

In 2026, FPI won’t just be about speed—it will be about predictability. Sponsors will expect sites to demonstrate real-time feasibility data before greenlighting activation.

How BEKhealth helps: BEKplatform identifies eligible patients instantly across 30M+ records, helping sites accelerate FPI and show evidence of readiness upfront.

2. Screen-Fail Rates as a Make-or-Break Performance Indicator

Screen-fail rates can reach as high as 20–80%, wasting staff resources and discouraging patients. Sponsors increasingly monitor this metric when evaluating site performance.

In 2026, screen-fail rates will be a critical factor in future site selection. Sites with consistently high failures risk being deprioritized.

How BEKhealth helps: By analyzing both structured and unstructured EHR data, BEKplatform reduces false positives—improving accuracy in pre-screening and lowering screen-fail rates.

3. Diversity Enrollment Benchmarks as a Regulatory Requirement

Diversity in clinical trials has shifted from aspiration to mandate. The FDA’s Diversity Action Plan (DAP) requirements under FDORA mean sponsors must demonstrate upfront how they’ll achieve representation goals.

In 2026, diversity enrollment benchmarks will be embedded into feasibility and site selection criteria, not just monitored mid-trial.

How BEKhealth helps: BEKplatform enables demographic and geographic queries across millions of patient records, allowing sponsors and sites to proactively identify underrepresented populations before a trial even begins.

4. Enrollment Velocity vs. Targets as a Competitive Differentiator

In the U.S., recruitment challenges are widespread and consequential. Nearly 80–85% of clinical trials fail to meet initial enrollment targets, while 37% of sites under-enroll volunteers, and 11% enroll no one at all. Moreover, about 30% of PIs fail to enroll even a single patient, highlighting how site underperformance is a consistent barrier to trial progress.

In 2026, enrollment velocity will be benchmarked not only against sponsor-set targets but also against peer site performance. High-performing sites will earn more trial opportunities.

How BEKhealth helps: BEK customers consistently identify up to 10x more qualified patients and achieve 2x faster enrollment, giving them a measurable edge in velocity.

5. Staff Hours per Enrollment as the New Efficiency Metric

In the U.S., digital innovation is already reshaping clinical trial workflows. The FDA has deployed a generative AI tool called Elsa to expedite scientific and protocol reviews—a sign that modernized, technology‑enabled processes are becoming integral to trial operations.

In 2026, sponsors will expect sites to document how they’re improving efficiency—tracking hours spent per enrollment as a key measure.

How BEKhealth helps: BEKplatform automates hundreds of hours of manual chart review per study, reducing cost per enrollment and freeing coordinators to focus on patient engagement.

The Sites That Win in 2026 Will Be Measured Differently

The metrics that define clinical trial success are shifting. In 2026, speed, accuracy, diversity, and efficiency will carry more weight than ever before. Sites and sponsors that track and improve these five enrollment benchmarks will be best positioned to win future studies and deliver breakthrough therapies faster.

BEKhealth was built for this future. By combining NLP and LLM technology with one of the largest patient networks in the industry, BEKplatform helps research teams accelerate timelines, improve precision, and ease staff burden.

Contact us to learn how BEKplatform can help your team stay ahead of 2026’s enrollment challenges.