Site enrollment

How sponsors can rescue an underperforming clinical trial site

By TrialNotice · Updated
Principal investigator pointing at a whiteboard of sticky notes while a sponsor manager looks on in an office at dusk
Short answerSponsors can rescue an underperforming site by diagnosing where its funnel breaks, adding patient sources the site lacks, such as funded physician referral outreach, reviewing criteria that drive screen failures, and only then adding or replacing sites. Replacement is costly: Phesi estimates a site that enrolls one patient over 30 months costs about $130,000.

How common are underperforming sites?

Very. In a typical trial, 11% of sites enroll no patients and 37% under enroll (Tufts CSDD via Fierce Biotech). A Phesi analysis of 173 cancer trials found the top 16% of sites contributed 54% of patients, while 19% of sites contributed less than 3% (Applied Clinical Trials).

What does an underperforming site cost?

Phesi estimates that with a $40,000 activation cost and $3,000 per month to manage a site, a 30 month study where a site enrolls one patient costs about $130,000 for that site alone (Applied Clinical Trials). Rescuing a site that already has an investigator, IRB approval, and staff is often cheaper than starting a new one.

What are the rescue options?

  1. Diagnose the funnel. Is the site short of candidates, failing them at screening, or losing them at consent? Each needs a different fix.
  2. Add patient sources. Many sites rely only on their own records. Funding physician referral outreach gives the site access to local physicians, who refer less than 0.2% of their patients mainly because they lack study information and time (Tufts CSDD).
  3. Attack screen failure. The average screen failure rate rose to 36.3%, and to 57% in CNS trials (Tufts CSDD). Review which criteria cause most failures across sites.
  4. Consider protocol changes. Eligibility criteria in a typical Phase III protocol rose from 31 to 50 between 2002 and 2012 (Tufts CSDD, Getz). If one criterion drives failures everywhere, an amendment may help more than any site intervention.
  5. Add or replace sites last, once the cheaper options are exhausted.

What should sponsors ask the site?

Ask for funnel counts by stage and by source, the top three screen failure reasons, and which patient sources the site is not using. A site that cannot answer needs process support before it needs more money.

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.

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Sources

  1. Tufts CSDD, patient recruitment and retention practices study (Jan 2013), via Fierce Biotech
  2. Applied Clinical Trials, "Phesi Report: Assessing Single Patient Investigator Sites in Cancer Clinical Trials"
  3. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  4. Ken Getz, Tufts CSDD, "The Cost of Clinical Trial Delays" (CTTI presentation)
  5. Applied Clinical Trials, "Tufts CSDD Study Explores Low Recruitment Rates"

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