Benchmarks and tools

Screen failure rates by therapeutic area: reference data

By TrialNotice · Updated
Hands sorting patient folders into green tabbed and amber tabbed stacks on an oak desk
Short answerThe average screen failure rate across Phase II and III trials is 36.3%, according to Tufts CSDD, up from 34.7% in 2012. CNS and neuroscience trials average 57%, up from 29.5%. MASH therapeutic trials run 70 to 80%, mostly at the baseline liver biopsy. Published therapeutic area data beyond these is limited, so sites should track their own rates.
Bar chart of screen failure rates: 36.3% across all therapeutic areas, 57% in CNS, and about 75% in MASH

What are the published benchmarks?

StatisticFigureSource
All therapeutic areas, Phase II and III36.3% (34.7% in 2012)Tufts CSDD
CNS and neuroscience57% (29.5% in 2012)Tufts CSDD
MASH therapeutic trials70 to 80%JHEP Reports
Alzheimer's patients estimated to be trial eligible10 to 27%Alzheimer's Association and NIA
Patients screened per randomized patient, 25 practice trial7.2 average (1.4 to 19.8)PMC
Honest caveat: rigorous screen failure data by therapeutic area is scarce. Many figures circulating online have no traceable source. We list only what we could verify.

How do you calculate your own screen failure rate?

Screen failure rate = patients who signed consent but did not randomize ÷ patients who signed consent. Track it per study and per patient source. Rates by source show which channels send patients who actually qualify.

Why does the rate matter financially?

88% of sites say screen failures are not sufficiently covered (SCRS), and 42% say screen failure terms never or rarely cover actual screen fails (SCRS). Use your expected rate when negotiating, not the sponsor's assumption. See how to negotiate a clinical trial budget.

How do sites bring the rate down?

By improving who arrives at screening. Patients referred by a physician who already knows their diagnosis, medications, and history are prequalified on the criteria behind most failures. See how to lower screen failure rates.

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Sources

  1. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  2. "Non invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials," JHEP Reports, PubMed
  3. Alzheimer's Association and National Institute on Aging national recruitment strategy announcement (2018)
  4. "Site specific factors associated with clinical trial recruitment efficiency in general practice settings," PMC
  5. Society for Clinical Research Sites, Site Finances White Paper (2024)
  6. SCRS 2024 Global Site Landscape results, Site Solutions Summit

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