Site enrollment

How to reach first patient in faster after site activation

By TrialNotice · Updated
Clinical research coordinator welcoming the first study patient at a research clinic entrance
Short answerReach first patient in faster by doing recruitment work during startup instead of after it: identify likely candidates, brief referring physicians, and have prescreened candidates ready when the site initiation visit ends. Tufts CSDD found the stretch from site initiation to first patient in is the most variable part of startup, and physician practices reach first patient fastest.

How long does study startup take?

Tufts CSDD's benchmark measured 31.4 weeks from site identification to startup completion, a month longer than a decade earlier (Tufts CSDD). Getz summarized it bluntly: the cycle is not getting any faster (Clinical Leader). Tufts has continued updating these benchmarks, comparing site activation and enrollment metrics across 2012, 2019, and 2023 (PubMed).

Where is the time lost?

Mostly early, in the stretch from pre study visit to contract execution. But the single most variable interval is site initiation to first patient in (Applied Clinical Trials). That is the part of the clock a site controls most directly.

31.4 weeks
site identification to startup completion
9.9 weeks
faster startup at repeat or familiar sites

Which sites reach first patient fastest?

Physician practices reached first patient in fastest, while academic institutions and government funded sites took longest. Oncology and CNS studies had the longest cycle times to first patient in, and cardiovascular, infectious disease, and metabolic studies the shortest (Applied Clinical Trials).

What can a site do during startup?

  1. Identify likely candidates from your records, within what your IRB and privacy procedures allow before approval.
  2. Brief referring physicians. FDA guidance treats doctor to doctor letters as outside direct advertising review (FDA), though your IRB may set its own rules. Letters sent during startup mean referrals arrive around activation.
  3. Prepare screening logistics: lab kits, scheduling templates, and coordinator time blocked for the first two weeks.
  4. Line up first screens for the days right after the site initiation visit.

How should you measure it?

Track days from site initiation visit to first screen and to first randomization for every study. It is one of the clearest signals sponsors see. See the metrics sponsors track.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

Talk to TrialNotice

Sources

  1. Tufts CSDD, first comprehensive clinical site initiation benchmark (2018), via GlobeNewswire
  2. Applied Clinical Trials, "New Benchmarks for Trial Initiation Activities" (Tufts CSDD)
  3. Lamberti M.J. et al., "Benchmarking Site Activation and Patient Enrollment," Therapeutic Innovation and Regulatory Science, PubMed
  4. FDA, "Recruiting Study Subjects" guidance for IRBs and clinical investigators
  5. Clinical Leader, "Why Is Study Start Up Still So Inefficient?" (interview with Ken Getz, Tufts CSDD)

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