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October 23, 2026

2026 Patient Recruitment Roundup

Enrollment rate is one of the most consequential performance metrics in clinical operations, with delays in patient recruitment consistently cited as the leading cause of trial timeline overruns. Low enrollment rates lead to extended development timelines, increased costs, and delayed patient access to novel therapies.

The 2026 Patient Recruitment Roundup presents a comprehensive analysis of clinical trial recruitment rates across 19,880 industry-sponsored, Phase I–IV drug interventional trials completed between 2022 and 2025, excluding COVID-19 trials (data cutoff Sept. 1, 2026). The median enrollment rate (MER), measured as patients enrolled per site per month, serves as the primary benchmark for recruitment performance, stratified by phase, therapeutic area, geography, and drug modality.

Key topics covered in this white paper include:
  • Yearly enrollment rate and patient volume
  • Site counts by phase
  • Overall geographic MER
  • MER by therapeutic area
  • Biologics vs. small molecules

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FAQ

This white paper presents an analysis of clinical trial recruitment and enrollment rates from 2022–25, comparing them to 2010 rates as a baseline. It includes median enrollment rate (MER) by phase, therapeutic area, region, and modality; enrollment durations and site counts by phase; and seven findings, each with a planning implication.

The median enrollment rate (MER) is defined as the median number of patients enrolled per site per month across all trials with available actual enrollment data. It is distinct from planned enrollment rate and reflects real-world recruitment performance. All enrollment rate figures in the 2026 Patient Recruitment Roundup refer to MER unless otherwise stated.
Enrollment rate is one of the most consequential performance metrics in clinical operations, since delays in patient recruitment are consistently cited as the leading cause of trial timeline overruns. Low enrollment rates translate directly into extended development timelines, increased costs, and delayed patient access to novel therapies.
Combined MER during 2022–25 came in at 0.37 patients/site/month, a 51% decrease from 0.76 in 2010. On an annual basis, MER hit a low of 0.32 in 2024 and rebounded somewhat to 0.36 in 2025.
Median enrollment duration, measured in months from first patient to last patient in, has risen in every phase since 2010. Phase I more than doubled (7.9 months to 16.8–20.3 months), while Phase II rose 57–67% (12.2 months to 19.2–20.4 months), Phase IV 38–52% (14.4 months to 19.9–21.9 months), and Phase III 16–34% (14.2 months to 16.4–19.0 months).
Yes. Across all phases, trials with Asian sites consistently outperform North American and European sites on enrollment rate. For instance, in 2025, Asia posted an overall MER of 0.35, compared with 0.21 for North America and 0.17 for Europe.

MER varied widely by therapeutic area in the 2022–25 period. Oncology and rare disease trials recorded rates as low as 0.16 (oncology, 2025) and 0.17 (non-oncology rare disease, 2025), impacted by narrow eligibility criteria and limited patient populations. By contrast, metabolic disease and genitourinary trials performed well, coming in at highs of 0.84 (metabolic disease, 2024) and 1.00 (genitourinary, 2023).

Clinical trial enrollment rates across industry-sponsored Phase I–IV trials have declined significantly from 2010 benchmarks and remain challenged through the 2022–25 period. The combined MER of 0.37 for the period, alongside enrollment durations that have risen in every phase, represents a growing operational burden for industry. Sponsors that adapt their planning assumptions and site strategies to the 2022–25 benchmark reality will be better positioned to execute against increasingly competitive enrollment conditions.
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