Site growth

How to answer a feasibility questionnaire and win the study

By TrialNotice · Updated
Clinical research coordinator filling out a feasibility questionnaire on a laptop with a patient database report beside her
Short answerAnswer a feasibility questionnaire with numbers you can defend: count patients in your records who meet the key criteria, add what your referral sources can realistically send, and discount for screen failure. Sponsors already discount site projections because so many prove wrong, so a site whose estimates hold up gains a lasting advantage.

Why are most feasibility answers wrong?

Because they are made with incomplete information and little time. Researchers point to limited protocol information and time as the likely causes of overestimation (PLOS One). Sponsors respond by discounting estimates, and Getz reports that even adjusted estimates are accurate less than 10% of the time by sponsor accounts (Applied Clinical Trials). Over half of sites say the questionnaires themselves do not represent their capabilities (Advarra).

How do you build an estimate you can defend?

  1. Get the deciding criteria. Ask for the full inclusion and exclusion list if it is not attached.
  2. Query your records for patients meeting the three to five criteria that decide most cases.
  3. Apply realistic conversion. Not every eligible patient will consent.
  4. Discount for screen failure. If you lack your own data, start from the 36.3% industry average, or 57% for CNS trials (Tufts CSDD).
  5. Add referral sources separately. Estimate what your referring physicians can send, based on past referral volume, and show it as its own line.
Illustrative example: 60 patients in records meet the key criteria, 40% are expected to consent to screening, and screen failure is 36.3%. That yields about 15 randomized from records (60 x 0.40 x 0.637). If referring physicians sent 10 screenable patients on a comparable past study, add about 6 more. Estimate: roughly 21, with the method shown.

How do you document patient access?

Describe where patients will come from, not just how many: your record database, the specialties and practices in your referral network, and past referral volumes. Documented access is what separates a credible estimate from an optimistic one.

What should you ask the sponsor?

  • Is recruitment funded? In SCRS's 2024 survey, 53% of sites said they regularly pay for recruitment out of their own funds (SCRS).
  • How are screen failures paid? 42% of sites said screen failure terms never or rarely cover the actual number of screen fails (SCRS).
  • How many sites and what enrollment period? Competition among sites affects your realistic share.

What happens after you win?

Track actual enrollment against your estimate every week. Over time, a record of accurate forecasts becomes one of your strongest selling points. See how sponsors select sites.

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. Getz K., "Is Investigative Site Feasibility Feasible?" Applied Clinical Trials
  2. Advarra, "Modernizing Site Feasibility and Selection"
  3. "Enhancing site selection strategies in clinical trial recruitment using real world data modeling," PLOS One
  4. Applied Clinical Trials, "Can Recruitment and Retention Get Any Worse?" (Tufts CSDD screen failure study)
  5. SCRS 2024 Global Site Landscape results, Site Solutions Summit

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