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Report: Up to 60% of clinical trials don't survive their first year
Between 45% and 60% of new U.S. clinical trial sites shut down within one year, but trial volume and government funding can increase longevity, new research says.
New research from the Milken Institute has found that nearly half of clinical trial sites in the United States close within a year of opening, highlighting weaknesses in the infrastructure that supports drug development.
The report analyzed 24,950 phase 1–4 pharmaceutical clinical trials launched between 2017 and 2024 and found that between 45% and 60% of new sites closed after hosting only one study in their first year.
This failure rate makes trial sites three times more likely to shut down than new U.S. businesses. Sites that survived beyond the first year had much higher survival rates in later years, indicating how fragile the start-up period is.
The overall supply of sites also shifted over the study's duration.
For instance, from 2017 through 2021, the total supply of clinical trials grew, meaning more sites opened than closed.
Since 2022, closures have outpaced openings, shrinking the number of active sites. The researchers noted that this change occurred around the COVID-19 pandemic, when many site openings were delayed and trials sought to transition to "siteless" alternatives.
What drives clinical site longevity?
The strongest factor in whether a site remains active is scale. Sites that hosted multiple trials in their first year had far higher survival rates than those that hosted only one.
The study concluded that the number of trials at launch was the clearest predictor of longevity. But, of course, funding also plays a role.
Sites with at least one government-funded trial in their first year -- typically backed by the National Institutes of Health (NIH) -- showed the best survival rates, while industry-funded sites and those funded by medical entities such as hospitals or academic centers were less likely to survive.
It is unclear whether government funding itself enhances survival or whether stable sites are just simply better positioned to attract NIH investment, the report cautioned.
The research report also found that the phase of hosted trials was less influential.
Data shows that sites with at least one phase 4 trial in their first year had the best survival, while those with at least one phase 2 trial had the worst survival. The differences, however, were smaller than those observed for trial volume.
Geography was a factor in where sites opened but not in how long they lasted.
More than 70% of new sites between 2018 and 2023 opened in large metropolitan counties, compared to those regions' 56% share of the U.S. population. Despite this concentration, local conditions such as county poverty rate, median household income and insurance coverage showed little correlation with site survival.
The authors concluded that the volatility of trial sites is shaped more by the characteristics of hosted studies and funding structures than by the socioeconomic conditions of the locations where sites are based.
These findings confirm the risks of relying on single-study facilities that may not last past the first year. With overall site supply declining since 2022, sustaining trial capacity will depend on engaging sites in multiple studies and ensuring stable funding.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
