Patient enrollment challenges in clinical trials are extremely common, impacting up to 85% of trials and causing study costs to skyrocket. When our partner designed a Type 1 Diabetes clinical trial, it required participants to have previously used specific medications, vastly limiting patient options within their own databases.

Halfway through the CRO’s planned annulment timeline, it became clear that the patients available in the sites’ databases simply wouldn’t be enough. That’s when they chose to partner with AutoCruitment (a life sciences company that accelerates patient enrollment for clinical trials with a direct-to-patient digital recruitment approach).

This trial is not an anomaly, but rather, the norm: CROs struggle to hit or exceed their enrollment targets. But the right patient enrollment company will identify bottlenecks and deploy a targeted, multi-faceted strategy to accelerate clinical trial enrollment for CROs and improve patient qualification outcomes.

In this patient enrollment case study, we share exactly how our direct-to-patient strategies helped this Type 1 Diabetes clinical trial turn the tides and not only reach their enrollment goals, but surpass them.

The Challenge: Enrollment Delays Threatening Trial Timelines

Type 1 Diabetes (T1D) clinical trials are highly competitive. There are more than 9 million people around the world living with this condition, and many CROs are aggressively searching for treatments and cures. Upwards of 600 T1D studies happen annually in the US alone, all requiring a certain number of patients.

Generally, these trials can face familiar recruitment obstacles: tight timelines, difficulty reaching qualified patients, and limitations of site-based recruitment reach. To prevent recurring recruitment bottlenecks, the CRO needed broader reach and faster conversion beyond site databases. When these issues lead to patient enrollment setbacks, there’s a ripple effect throughout the study: delays on timelines, regulatory approval, and patient access to therapies.

In this Type 1 Diabetes patient enrollment case study, a CRO was unable to reach the number of patients who fit their criteria, and time was running out. With only 3.5 months remaining, and 282 randomized patients still needed, the CRO partnered with AutoCruitment to implement a rapid three-month targeted online recruitment campaign that included a customized, sophisticated online screener and dedicated site engagement support.

Our Solution: Direct-to-Patient Recruitment and Ongoing Support

To support this T1D clinical trial, AutoCruitment quickly launched a multi-faceted direct-to-patient campaign, using targeted digital advertising to expand reach far beyond traditional site databases.

This direct-to-patient recruitment model rapidly expanded access to patients while keeping eligibility standards high. We also provided comprehensive site and patient support throughout the enrollment process to drive results.

The Goals: The initial goals were to support 146 sites by sending 2,200 pre-screened patients and increase the enrollment rate from 87.5 to 112.8 patients per month.
Our Results: AutoCruitment exceeded expectations by referring 2,568 pre-screened patients and randomizing 64 patients, which boosted the enrollment rate to 141 patients per month, a 61% increase.

This achievement allowed screening to close two weeks ahead of the original deadline, resulting in an accelerated enrollment and saving a total of 1.5 months on the study timeline.

Let’s break down how we accomplished this, starting with direct-to-patient advertising. AutoCruitment’s proprietary Patient Management Platform uses online browser behavior and geotargeting to focus in on interested and qualified patients while they are searching online for information about their condition.

Our approach involves:

• Customized online screeners: We align study-specific online questionnaires to inclusion and exclusion criteria to qualify interest efficiently and reduce screen failure rates.
• EMR Capture & Intelligence: AutoCruitment’s platform streamlines EMR (electronic medical record) consent, standardization, and review processes for clinical research sites and patients. With this unique tool, CROs can capture consent, confirm patient identity, retrieve and organize medical records, and review patients for trial eligibility. Plus, standardized EMR Capture & Intelligence enabled consistent, rapid eligibility checks across sites.
• Clinical phone screening: AutoCruitment offers second-line clinical phone screening, which provides an additional layer of patient verification by further assessing patients’ eligibility against inclusion and exclusion criteria.

Additionally, for this Type 1 Diabetes clinical trial, AutoCruitment provided hands-on site engagement specialists, which was integral to the success of the study. Our site engagement teams created specialized recruitment plans with each of the 146 sites to ensure they all had a manageable number of qualified patients and the support they needed to succeed.

This hands-on approach resulted in sites being more motivated to contact patients and drive them towards randomization. By uniting digital outreach with a clear patient recruitment strategy, the team converted interest into qualified visits at scale. Together with our centralized Patient Management Portal, sites gained clear visibility into referral status and next steps.

For this study, our patient enrollment strategy was highly effective: 48 participating sites successfully randomized at least one patient recruited by AutoCruitment, and the top-enrolling site randomized five patients throughout the campaign.

Exceeding Enrollment Targets

When this CRO partnered with AutoCruitment, they achieved measurable results:

• 50,176 patients interested
• 2,568 passed the online screener
• 497 patients passed the phone screener
• 48 sites randomized at least 1 AutoCruitment patient
• 1.5 months saved
• Enrollment increased by 61%
• AutoCruitment contributed 22% of randomized participants

These outcomes demonstrate how AutoCruitment’s disciplined enrollment planning and advanced recruitment strategies and tools achieve (and in this case exceed) clinical trial success.

Key Takeaways for CROs

Clinical trials sponsors don’t have to accept recruitment challenges as the status quo. When CROs partner with AutoCruitment, they can reach more patients, qualify them faster, and keep their timelines (and budgets) on track.

If you’re considering AutoCruitment’s direct-to-patient recruitment, remember that:

• Our direct-to-patient recruitment eliminates bottlenecks and broadens access: Site resources and physician referrals alone have inherent limits. Layering in global, direct-to-patient outreach surfaces more eligible patients beyond those channels, accelerating patient enrollment, outreach, and qualification.
• Our technology-driven processes ensure efficiency: Real-time reporting and our secure Patient Management Portal provide study teams with transparent pipeline views, while our EMR Capture & Intelligence and customized online screeners enhance qualification quality and reduce redundant processes.
• Our dedicated teams provide CROs with seamless execution and constant support: Our project management, patient engagement, and site engagement teams keep recruitment moving, align stakeholders to enrollment and randomization goals, and resolve issues quickly across countries and sites.

Bottom line: When CROs partner with AutoCruitment to combine direct-to-patient recruitment with smart tech and hands-on support, enrollment becomes a managed, measurable flow.

We put EMR Capture & Intelligence, customized screeners, and a Patient Management Portal at the core of recruitment; then let dedicated project, patient engagement, and site engagement teams maintain the momentum. Our approach consistently expands reach, lifts qualification quality, and hits randomization targets with fewer surprises study after study.

Unlocking Faster, More Effective Patient Recruitment

In this Type 1 Diabetes clinical trial, the CRO was struggling to meet their patient enrollment targets and was unable to find enough patients who fit their specific criteria. But when they leveraged AutoCruitment’s direct-to-patient approach, they not only hit their enrollment targets but surpassed their timeline goals, saving valuable resources.

The evolution of patient enrollment is clear: Direct-to-patient recruitment provides a strategic advantage for future studies, ensuring on-time, on-budget trial success.

And no one does it better than we do! Contact AutoCruitment to see how direct-to-patient recruitment can accelerate or rescue your trial.