Site enrollment

Behind on enrollment: a recovery plan for clinical research sites

By TrialNotice · Updated
Two research site staff members arranging sticky notes on a weekly planning whiteboard
Short answerDiagnose where patients are dropping out of your funnel, work your own records again with clinical staff assigned to find candidates, add a physician referral source, and report progress to your sponsor weekly. Falling behind is common: Tufts CSDD found 37% of sites under enroll and 11% enroll no patients at all.

How common is falling behind on enrollment?

In a typical trial, 11% of sites enroll no patients and 37% under enroll, according to Tufts CSDD's study of nearly 16,000 sites (Tufts CSDD via Fierce Biotech). Protocols have also become harder to fill: the number of eligibility criteria in a typical Phase III protocol rose from 31 to 50 between 2002 and 2012 (Tufts CSDD, Getz).

Step one: where is your funnel leaking?

Count patients at each stage: identified, prescreened, screened, consented, randomized. The gaps tell you what to fix. In a trial run across 25 general practices, the number of patients screened for each one randomized averaged 7.2 but ranged from 1.4 to 19.8 between sites (PMC). Two sites on the same protocol can have very different problems.

  • Too few identified: you need more patient sources.
  • High screen failure: your sources are sending the wrong patients, or the criteria are not understood.
  • Consent drop off: look at visit burden and how the study is explained.

Step two: work your own records again

In the same general practice study, the strongest factor linked to recruitment efficiency was assigning clinical staff to identify potential participants (PMC). Give a named person protected time to review charts against the protocol, and recheck patients who were close to eligible earlier.

Step three: add a physician referral source

Local physicians who treat your study population are the source most sites leave untouched. They refer less than 0.2% of their patients into trials, mostly because they lack study information and time (Tufts CSDD). Send them a specific study summary, make referral one step, and follow up. See how to get physicians to refer.

Step four: report to your sponsor weekly

Sponsors track site performance closely because under enrolling sites are expensive: Phesi estimates a site that enrolls one patient over a 30 month study costs the sponsor about $130,000 (Applied Clinical Trials). A clear weekly report on the funnel and the new sources you have added protects your standing for the next study.

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, patient recruitment and retention practices study (Jan 2013), via Fierce Biotech
  2. "Site specific factors associated with clinical trial recruitment efficiency in general practice settings," PMC
  3. Ken Getz, Tufts CSDD, "The Cost of Clinical Trial Delays" (CTTI presentation)
  4. Applied Clinical Trials, "Tufts CSDD Study Explores Low Recruitment Rates"
  5. Applied Clinical Trials, "Phesi Report: Assessing Single Patient Investigator Sites in Cancer Clinical Trials"

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