Patient recruitment

How to write a patient recruitment plan for a clinical trial

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 enrollment target and timeline, the funnel assumptions behind it, each patient source with its expected yield and cost, the materials and approvals needed, screening capacity, and the weekly metrics you will review. Plans that depend on a single source are the ones that fail; strong plans combine records, physician referrals, and advertising with numbers for each.

Why write a recruitment plan at all?

Because recruitment is the problem sites rank first, at 65% in SCRS's survey (SCRS), and a plan is how you turn it from hope into math. Tufts CSDD's benchmarking work now tracks which recruitment and retention tactics sites use alongside activation and enrollment metrics (PubMed), a sign of how central planned recruitment has become.

What are the sections of a recruitment plan?

  1. Target and timeline. Randomizations needed and the enrollment window.
  2. Funnel assumptions. Expected consent and screen failure rates. Use your own history, or start from the 36.3% average (Tufts CSDD).
  3. Patient sources. One line per source with expected candidates per month.
  4. Materials and approvals. Patient facing ads and flyers need IRB review; FDA guidance treats doctor to doctor letters differently (FDA). Confirm with your IRB.
  5. Budget. Cost per source. 53% of sites regularly pay for recruitment from their own funds (SCRS), so negotiate recruitment funding into the study budget.
  6. Staffing and screening capacity. In one trial, recruitment took 3.7 staff hours per randomized patient (PMC).
  7. Metrics and review cadence. Weekly funnel by source.
  8. Contingency triggers. What you will add if you miss targets two weeks running.

Which patient sources belong in the plan?

  • Site records: fastest to start, limited volume.
  • Physician referrals: patients with established diagnoses; needs lead time. See how to get physicians to refer.
  • Advertising: a meta analysis found online recruitment cost $72 per enrollee versus $199 offline, while offline methods converted better in 69% of comparisons (JMIR).
  • Community outreach: events and partnerships, strongest for conditions with engaged patient communities.

How do you keep the plan alive?

Review it weekly against actual numbers by source, and move effort toward the sources producing randomized patients. A plan that is never updated is just a feasibility estimate with more pages. See how to meet an enrollment deadline.

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. Society for Clinical Research Sites, 2022 Site Landscape Survey White Paper
  2. Lamberti M.J. et al., "Benchmarking Site Activation and Patient Enrollment," Therapeutic Innovation and Regulatory Science, PubMed
  3. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  4. Brøgger Mikkelsen M. et al., "Online Patient Recruitment in Clinical Trials: Systematic Review and Meta Analysis," Journal of Medical Internet Research
  5. "Site specific factors associated with clinical trial recruitment efficiency in general practice settings," PMC
  6. SCRS 2024 Global Site Landscape results, Site Solutions Summit
  7. FDA, "Recruiting Study Subjects" guidance for IRBs and clinical investigators

Keep reading

Clinical research coordinator in navy scrubs talking with an older male patient in a bright consultation room
Patient recruitment

How to recruit more patients for a clinical trial at your site

Research sites recruit from three sources: their own records, advertising, and physician referrals. Physician referral is the most underused. Here is how to work all three with verified data behind each.

 Older couple reading a brochure together in a bright family practice waiting room
Patient recruitment

Where patients actually learn about clinical trials

Most people say they would ask their doctor first about clinical trials, but few are ever asked. Here is what CISCRP and other research show about how patients find trials, and what it means for sites.

 Community physician in a white coat reading a one page clinical trial referral letter at his office desk
Physician referrals

How to get physicians to refer patients to your clinical trial

Physicians refer less than 0.2% of their patients into clinical trials, mostly because they lack study information and time. Here is how research sites close that gap and build a steady referral pipeline.