Benchmarks and tools

Patient recruitment plan template for clinical trial sites

By TrialNotice · Updated
Clinical research team mapping a patient recruitment plan on a glass wall with colored markers
Short answerA patient recruitment plan states the target and timeline, the funnel assumptions behind it, each patient source with expected yield, materials and approvals, budget, screening capacity, weekly metrics, and contingency triggers. The template below covers all eight sections and is ready to copy and fill in.
PATIENT RECRUITMENT PLAN Study: [protocol number and short title] Site: [site name] Principal Investigator: [name] Prepared: [date] 1. TARGET AND TIMELINE Randomizations needed: [number] Enrollment window: [start date] to [end date] ([number] weeks) Required pace: [randomizations per week] 2. FUNNEL ASSUMPTIONS Consent to screen rate: [percent] Expected screen failure rate: [percent] (industry average 36.3%) Expected dropout rate: [percent] (industry average 19.1%) 3. PATIENT SOURCES (one line each) Site records: [expected candidates per month] Physician referrals: [specialties, number of practices, expected candidates per month] Advertising: [channels, expected candidates per month] Community outreach: [events or partners, expected candidates per month] 4. MATERIALS AND APPROVALS Patient facing materials submitted to IRB: [list and dates] Physician letter: [confirm IRB policy] 5. BUDGET Cost per source: [list] Sponsor funded recruitment line: [amount or none] 6. STAFFING AND SCREENING CAPACITY Recruitment owner: [name] Screening slots per week: [number] 7. METRICS AND REVIEW Weekly review: [day and attendees] Tracked by source: candidates, screens, randomizations, screen failure reasons 8. CONTINGENCY TRIGGERS If below pace two weeks running: [actions]

Where do the default benchmarks come from?

  • Screen failure 36.3% and dropout 19.1%: Tufts CSDD Phase II and III averages (Tufts CSDD).
  • Why budget matters: 53% of sites regularly pay for recruitment from their own funds (SCRS), so the plan should name what the sponsor funds.
  • Approvals: FDA treats ads and flyers for prospective subjects as materials IRBs review (FDA).
  • Staffing: one 25 practice trial measured 3.7 staff hours per randomized patient (PMC).

How do you keep the plan useful?

Review it weekly against actual numbers by source. Recruitment is the improvement area sites rank first, at 65% in SCRS's survey (SCRS); a plan that is updated weekly is how it gets managed rather than hoped for. See how to write a recruitment plan.

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. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  2. Society for Clinical Research Sites, 2022 Site Landscape Survey White Paper
  3. SCRS 2024 Global Site Landscape results, Site Solutions Summit
  4. FDA, "Recruiting Study Subjects" guidance for IRBs and clinical investigators
  5. "Site specific factors associated with clinical trial recruitment efficiency in general practice settings," PMC

Keep reading

Research site manager looking at a monitor showing an enrollment bar chart falling below a red target line
Benchmarks and tools

Clinical trial enrollment statistics: the complete reference

The verified numbers on site enrollment: how many sites miss targets, how enrollment concentrates, screen failure, dropout, activation, and protocol complexity. Every figure links to its original source.

 Hands sorting patient folders into green tabbed and amber tabbed stacks on an oak desk
Benchmarks and tools

Screen failure rates by therapeutic area: reference data

Published screen failure benchmarks: 36.3% across therapeutic areas, 57% in CNS, and 70 to 80% in MASH. Plus how to calculate your own rate and use it in budgets and forecasts.

 Clinical research coordinator welcoming the first study patient at a research clinic entrance
Benchmarks and tools

Site activation and study startup benchmarks

Tufts CSDD benchmarks for study startup: 31.4 weeks from site identification to startup completion, 9.9 weeks faster at repeat sites, and only 62% of North American sites activating.