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

Halfway through their 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 rarely hit or exceed their enrollment targets. But the right patient enrollment company will diagnose your 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 AutoCruitment’s 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 bottlenecks: tight timelines, difficulty reaching qualified patients, and limitations of site-based recruitment reach. To prevent a recurring recruitment bottleneck, the CRO needed broader reach and faster conversion beyond site databases. When these issues lead to patient enrollment delays, there’s a ripple effect throughout the study: delays on budget, regulatory approval, and patient access to therapies.

In our Type 1 Diabetes patient enrollment case study, we were unable to reach the number of patients who fit our criteria, and time was running out. With only 3.5 months remaining and 282 randomized patients still needed, AutoCruitment was chosen to implement a rapid three-month targeted online recruitment campaign, utilizing a customized and sophisticated online screener for the study, including dedicated Site Engagement support.

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

In this particular patient enrollment case study, AutoCruitment initiated a multi-faceted clinical trial support campaign rooted in its direct-to-patient approach, using targeted digital advertising to expand reach far beyond traditional site databases. 

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

Here’s an overview of our goal and the results:

• Goal: The initial goal was to support 146 sites by sending 2,200 pre-screened patients and increasing the enrollment rate from 87.5 to 112.8 patients per month. 
• 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 this was accomplished, starting with direct-to-patient advertising. AutoCruitment’s proprietary technology platform uses online browser behavior and geotargeting to target interested and qualified patients while they are online searching for information on their condition. 

This approach involves:

• Customized online screeners: Study-specific online questionnaires aligned to inclusion and exclusion criteria to qualify interest efficiently and reduce screen failure rates.
• EMR Capture & Intelligence: AutoCruitment’s system streamlines the EMR (Electronic Medical Record) consent, standardization, and review process for clinical research sites and patients. With this tool, CROs can capture consent, confirm patient identity, retrieve and organize medical records, and review patients for trial eligibility. Standardizing on EMR capture and intelligence enabled consistent, rapid eligibility checks across sites.
• Clinical phone screening: While this stage isn’t used in every trial, AutoCruitment offers second-line clinical phone screening, which provides an additional layer of patient verification by further assessing patients’ eligibility against the study inclusion and exclusion criteria.

Additionally, for our Type 1 Diabetes case study, AutoCruitment provided hands-on Site Engagement, which was integral to the success of this study. You’ll recall: There were 146 sites involved with this effort. Our Site Engagement teams created specialized recruitment plans with each site to ensure they had a manageable number of qualified patients and the support they needed to succeed. 

It 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 a centralized patient management portal, sites gained clear visibility into referral status and next steps.

During this particular patient enrollment case study, this work was highly effective: 48 participating sites successfully randomized at least one patient recruited by AutoCruitment, and the top-enrolling site randomized five patients through the campaign.

Results: Exceeding Enrollment Targets

When this Type 1 Diabetes study partnered with AutoCruitment, they saw measurable results.

Working with AutoCruitment resulted in:

• 50,176 patients interested
• 2,568 passed the online screen
• 497 patients passed the phone screen
• 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 disciplined enrollment planning translates into measurable clinical trial success.

Key Takeaways for CROs

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

If you’re involved in a CRO and you’re considering direct-to-patient recruitment, remember that:

• Direct-to-patient recruitment eliminates bottlenecks and broadens access: Site resources and physician referrals have inherent limits. Layering in global, direct-to-patient outreach surfaces more eligible patients beyond those channels, accelerating patient enrollment, outreach, and qualification. 
• Technology-driven processes ensure efficiency: Real-time reporting and secure Patient Management Portals provide study teams with transparent pipeline views, while EMR Capture & Intelligence and customized online screeners enhance qualification quality and reduce redundant processes.
• Dedicated teams provide CROs with seamless execution and constant support: Project Management, Patient Engagement, and Site Engagement resources keep recruitment moving, aligns stakeholders to enrollment and randomization goals, and resolves issues quickly across countries and sites.

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

Put EMR Capture & Intelligence, online screeners, and a Patient Management Portal at the core; then let dedicated Project, Patient Engagement, and Site Engagement teams keep the momentum. Do this consistently, and you’ll expand reach, lift qualification quality, and hit randomization targets with fewer surprises study after study.

Unlocking Faster, More Effective Clinical Trials

In this Type 1 Diabetes patient enrollment case study, 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 also surpassed their timeline goals, saving valuable resources. 

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

Ready to accelerate? Contact AutoCruitment to see how direct-to-patient recruitment can accelerate your trial.