Successfully recruiting potential patients for clinical trials lays the foundation for achieving life-altering medical advancements and improving patient outcomes. However, expressing interest and willingness doesn’t guarantee participation; many patients who try to enroll are determined ineligible, contributing to screen fail rates.

Screen fails only waste invaluable time and budgets, with 85% of clinical trials experiencing these types of recruitment-related setbacks. And for each day a clinical trial suffers delays, broader patient populations continue to lack access to treatment.

In contrast, trial organizers incur an average of $800,000 in losses, according to research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD).

Contract research organizations (CROs), sponsors, and other trial stakeholders struggling to reach their recruitment targets need to adopt new strategies that better qualify potential patients and reduce screen fail rates.

In particular, partnering with patient recruitment vendors enables clinical trials to implement and optimize their online and phone screening processes—conducting effective, efficient, and early pre-screening without touching protocol design. Here’s how.

Why Screen Fail Rates Matter in Clinical Trials

Within the context of clinical trial recruitment, screen fail rates refer to the percentage of potential participants who begin but don’t complete the enrollment process after being deemed ineligible. While ineligibility can be determined for various reasons, the most common tend to be not meeting inclusion criteria or meeting exclusion criteria.

However, this isn’t typically discovered until their medical histories are reviewed or consenting patients undergo initial examinations, laboratory tests, and imaging.

While research on screen failures is somewhat limited—due to many trials not reporting the reasons determining patients’ ineligibility—systematic reviews of similarly designed studies generally support this understanding.

For example, one analysis of 15 trials studying oncology treatments found “not meeting inclusion criteria” accounted for roughly 55% of screen fails; another analysis of 87 trials related to studying retinal diseases found a screen fail distribution of:

• 44.5%: Did not meet imaging-based inclusion criteria
• 15.1%: Met exclusion criteria
• 14.7%: Did not meet vision-based inclusion criteria
• 7.8%: Due to miscellaneous reasons
• 6.8%: Due to patient decisions
• 5.6%: Due to physician-related reasons
• 5.4%: Due to unavailable reasons

Considerable downstream impacts occur as a result of these screen fails, including delayed timelines, frustrated and overextended site staff, budget overages, and poor recruitment outcomes.

Additionally, given that randomized clinical trials should maintain sufficient patient diversity to better assess the effects of treatment, screen fails among already small groups of potentially eligible patients can inadvertently and disproportionately impact demographics commonly underrepresented.

However, many of these screen fails could be caught by the right patient recruitment, screening, and engagement strategies before potential candidates even get to their first site visit. Filtering eligibility earlier in the recruitment process yields more qualified patient pools, with the following downstream benefits: Adhering to timelines and budgets, reclaiming bandwidth for site personnel to facilitate improved patient experiences, and collecting more accurate data.

Key Causes of Screen Fails Before Patient Enrollment

If biopharmaceutical companies determine the eligibility criteria that patients must meet before recruitment begins, why do they contend with such high screen failure rates? Simply put, misalignments between screening criteria and recruitment tactics result in more ineligible patients trying to enroll. Addressing these misalignments provides the most immediate and effective method to improve screen fail rates.

Before patients ever undergo site-level screening, various recruiting touchpoints often inadequately inform, target, or filter potential enrollees:

• Poorly targeted outreach results in fewer eligible patients becoming aware of the trial.
• Messaging that’s too broad or fails to inform about determining eligibility criteria causes more ineligible patients to think they can enroll—taxing recruitment and screening resources.
• Online screening that lacks filtering questions and inconsistent or skipped phone screening won’t effectively stop ineligible patients from progressing through the recruitment funnel.

Therefore, to boost screen failure rates, organizers should evaluate and optimize three different types of early touchpoints with clinical trial recruitment tools: Digital marketing, online screening, and phone screening (or other secondary screening strategies).

Targeted Recruitment Strategies to Reduce Screen Fail Rates

To optimize recruitment and screening success, clinical trial strategies should start by expanding on traditional recruitment strategies with targeted, digital patient recruitment efforts. If your outreach still relies exclusively on pamphlets and physician referrals rather than modern technology, it’s far too easy to miss eligible and motivated patients.

In some cases, projects may reach broader audiences through multiple sites, but this should not be confused with decentralized clinical trials (DCTs), which are defined by their use of remote technologies and procedures rather than just multiple locations.

However, site-based recruitment still can’t match digital targeting capabilities that benefit from user activity data. By leveraging social media and search engine ads, companies can more easily pinpoint and spread awareness to potential patients.

However, before launching a digital campaign to recruit more patients, companies must adhere to specific regulations and best practices to ensure compliance and maximize effectiveness.

To start, it’s especially crucial to ensure all marketing material and copy is approved by the Institutional Review Board (IRB). Otherwise, you risk noncompliance. The messaging should also clearly indicate eligibility criteria.

Additionally, when building and launching digital campaigns, you can attract the most qualified potential participants and achieve the best results by segmenting different patient audiences. Otherwise, campaigns remain too broad, leading to an increase in unqualified applications.

Appealing to different audience segments—grouped by factors such as age, gender identity, and even spoken languages—often requires building and refining campaigns specific to each segment.

By breaking up the total pool of potential patients into smaller and more homogenous groups, it becomes easier to first identify the channels and digital spaces they gravitate toward and then evaluate which messaging is the most compelling (e.g., A/B testing).

How Online Screeners Help Apply Exclusion Criteria Early

To more effectively sift through candidates for a clinical trial, CROs, sponsors, and other stakeholders should implement thorough online screening capabilities to act as a top-level filter.

Well-built, customized online screeners will provide more information about inclusion and exclusion criteria to potential participants as well as better capture relevant information (within acceptable scope)—educating them and offering more agency in their patient journey while more easily eliminating ineligible candidates.

Moreover, for every ineligible candidate eliminated via online screening, research site staff can retain more bandwidth and resources to focus on and attend to the eligible patients.

This creates higher-quality interactions between patients and engagement specialists. By fostering better patient experiences and setting clear expectations, online screeners play a significant role in contributing to long-term patient retention.

Use Phone Screening to Ensure Protocol Compliance and Improve Accuracy

Although well-built online screeners provide an effective top-level filter, some ineligible patients will inevitably enter the recruitment funnel. This could occur because the potential patient entered ambiguous responses or because they didn’t fully understand the inclusion and exclusion criteria as provided.

Implementing phone screening or partnering with a clinical phone screening service will better refine the pool of potential participants. Patient engagement specialists will contact everyone who passes the online screening stage to more thoroughly validate candidates before referring them to a site.

Effective phone screening can reduce the number of wasted lab tests, imaging, and other time- and resource-consuming assessments. Especially regarding medical histories, phone screening will improve recruitment accuracy and better ensure protocol compliance.

And just as professional online screening establishes impactful first impressions, phone screening provides a critical touchpoint. By empathetically engaging with candidates over the phone, specialists further enhance patient experience, satisfaction, and trust.

Case Study: How AutoCruitment Helps Minimize Screen Fail Rates

Partnering with AutoCruitment will equip trials with the patient recruitment solutions to capitalize on all three methods of improving screen fail rates.

Starting with direct-to-patient (DTP) digital marketing strategies, AutoCruitment will develop and launch FDA- and IRB-compliant campaigns across social media and other channels.

Based upon advanced algorithms, the messaging and study- or indication-specific language and images will more directly target the precise populations and motivated individuals required for the study.

These campaigns simultaneously expand marketing reach while pre-filtering recipients based on core criteria. Subsequent rounds of customized online screening and (optional) phone screening will further pre-qualify enrollees to drastically reduce screen fail rates. With transparent reporting, trial organizers can monitor performance, feedback, and enrollment data in real-time.

In one Phase III Uterine Fibroid study, the screen fail rate hovered around 90% after trying to fill five treatment groups and 600 randomized enrollments—a pace that would overshoot their remaining timeline by 10 months unless the enrollment rate nearly tripled.

But by partnering with Autocruitment, the researchers were able to launch a DTP campaign that reached nearly 200,000 interested individuals.

This number was pre-screened down to roughly 40,000 through online screening, and then further reduced to just over 10,000 via phone screening. Not only did the clinical trial meet its enrollment goal on time, but AutoCruitment exceeded the previous enrollment rate by 175% while contributing one-third of all randomized participants.

Improving Patient Recruitment Accuracy With the AutoCruitment Approach

Screen fail rates represent a significant and rigorous hurdle in nearly every clinical trial, exacerbating delays and costs while taxing site personnel. However, CROs, sponsors, and other stakeholders can considerably boost enrollment and accelerate timelines simply by partnering with an expert recruitment vendor that implements smarter, more targeted pre-screening.

No protocol changes are necessary whatsoever—so long as you partner with experts like AutoCruitment that repeatedly demonstrate results.

Want to reduce screen fail rates and recruit more qualified participants?

Contact AutoCruitment to learn how our custom screening solutions can help.