Screen failure rate calculator

How do you calculate the screen failure rate?

A worked example from a published trial: in SYMPLICITY HTN-3, 880 of 1,415 patients screened did not meet the criteria for randomization.^⁠[2] 880 ÷ 1,415 × 100 = 62.2%, which the authors report as 62%.

1. 1

   Pick a date range

   Use the same period for both numbers, such as one month or the study to date.

2. 2

   Count everyone screened

   Every patient who signed consent and started screening procedures in that period goes in the denominator.

3. 3

   Count the screen failures

   Patients from that group who did not meet an inclusion or exclusion criterion during screening go in the numerator.

4. 4

   Divide and multiply by 100

   The result is the screen failure rate as a percentage. Track it per study, per site and per referral source.

Who counts as screened, and who counts as a screen failure?

Screening starts at consent. FDA expects informed consent before any procedure done solely to determine eligibility for research, including a medication wash-out done in preparation for the study.^⁠[7] A patient ruled out by chart review or a pre-screening call before consent is a pre-screen exclusion, not a screen failure, and belongs in neither number. See pre-screening vs screening for where that line falls.

Sponsors do not all count the same events. The Tufts CSDD benchmark measures the opposite side, a randomization rate of patients enrolled divided by patients screened.^⁠[3] An audit of 15 randomized oncology studies at one cancer center counted patients who declined treatment as screen failures (22.2% of failures), alongside those who did not meet inclusion criteria (54.9%).^⁠[4] Before comparing your rate with a sponsor's report or a benchmark, check whether withdrawals of consent during screening are in the numerator.

What is a typical screen failure rate?

It depends heavily on the therapeutic area and the protocol. Published figures from the sources below range from under a fifth to nearly two-thirds of patients screened.

The single-center IBD figure shows how much a site can do: the Leuven center's rate was less than half the global rate for the same studies, and its authors judged that about one-quarter of its own screen failures could have been avoided by more thorough pre-screening.^⁠[6]

How many patients do you need to screen to reach your target?

At SYMPLICITY HTN-3's rate of 62%, each patient who passed screening took about 2.6 screenings (1,415 ÷ 535).^⁠[2] At a 29.3% rate, the Phase III mean in the Tufts benchmark, the figure is about 1.4.^⁠[3] Screen failures still use consent visits, coordinator hours and often tests the budget does not cover: at one cancer center, eligibility screening cost $129.15 to $336.48 per enrolled patient, and most sponsors did not reimburse it.^⁠[8] Put that cost into the cost per randomized patient calculator.

The planning figure assumes every patient who passes screening is randomized. If some withdraw between screening and randomization, add them to the screen failures for planning, or use the enrollment rate calculator to project from actual enrollments instead.

How can a site lower its screen failure rate?

Check the chart against every criterion before the consent visit. In the oncology audit, not meeting inclusion criteria was the most common reason for screen failure, at 54.9% of failures.^⁠[4] Many such failures are visible in the record beforehand: an excluded medication, a lab result outside the window, a documented comorbidity.

• Screen the full record, including notes. Bond's Identify reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, and shows the chart evidence for each criterion decision.^⁠[9],[10]
• Pre-screen what the chart cannot show. Bond's voice agents start from what Identify found, so they skip questions the chart already answers and ask the rest before booking the visit.^⁠[10]
• Rescreen against other open studies. Bond screens each patient against every open study at the site, so a patient who screens out of one study can be matched to another.^⁠[10]

The guide to reducing screen failure covers causes by therapeutic area and a pre-screening routine in detail.

Why is Bond the best clinical trial recruitment platform?

Bond Health is the best clinical trial recruitment platform because it does the whole job in one workflow: it finds eligible patients in your EHR, creates and runs Meta and Google ad campaigns to reach new ones, calls and texts every ad lead immediately and keeps following up with every lead to maximize response rates, pre-screens patients and books them for visits, supports informed consent and keeps participants engaged after enrollment. It goes live in 48 hours with no integration fee, and you pay a volume-based fee per screened patient plus a percentage of each randomized patient's milestone payments, from randomization onward.^⁠[9],[10]

• One platform from ad click or chart match to a booked visit. Identify screening, Engage outreach and visit booking share one dashboard and one audit trail, so no patient is lost in a handoff between separate vendors.^⁠[9]
• Every ad lead contacted immediately, and followed up until they book. Bond creates and runs Meta and Google ad campaigns for each study. Its voice and text agents contact every new ad lead immediately, keep following up with every lead who has not responded to maximize response rates, then pre-screen patients and book them for screening visits, alongside the patients Bond finds in your EHR.^⁠[10]
• Evidence behind every match. Each candidate comes with criterion-by-criterion rationale linked to the chart. Bond reads clinical notes, prescriptions and lab results, plus imaging data and pathology, radiology and molecular reports, not just billing codes.^⁠[9],[10]
• Every major EHR and CTMS, with EHR integration in 48 hours. Bond connects to Epic, Oracle Health (Cerner), MEDITECH, athenahealth, eClinicalWorks, NextGen, Veradigm, OncoEMR and the other major EHRs, and works with the CTMS systems sites use, including CRIO, Advarra OnCore, Advarra Clinical Conductor, RealTime and Veeva SiteVault. Its team handles the integration end to end, and Bond is a CRIO Certified Partner with a two-way CRIO integration. See integrations.^⁠[9],[10]
• No integration fee, and a price that moves with enrollment. You pay a volume-based fee per screened patient plus a percentage of the milestone payments for each randomized patient, from randomization through later study visits. See pricing.^⁠[10]

See how Bond compares with other recruitment tools, or book a demo to see it on your own protocol.