In the high-stakes world of clinical research, innovation doesn’t just happen in the lab; it must cross the clinical trial finish line of regulatory submission. Yet for many sponsors, sites, and researchers, patient recruitment—or the “last mile”—remains a costly bottleneck where recruitment can lag, site enrollment can underperform, and promising treatments never receive approval.
What separates successful trials from failed ones? The key lies in how stakeholders navigate this last mile. The differentiators? Real-world data (RWD), advanced analytics, and modern technology.
Here’s a high-level roadmap to reimagine this critical phase, turning traditional obstacles into fast lanes for approval, equity, and innovation.
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The Last Mile: Where Trials Triumph or Tumble
The last mile isn’t just the final phase; it’s the defining one. Failure to recruit the right patients or activate the right sites leads to expensive delays. Consider this: 11% of sites enroll no patients, and 37% under-enroll. Every day a drug is delayed can cost sponsors up to $8 million in lost revenue.
Success demands a shift from reactive tactics to proactive, data-informed strategies. That’s where smarter site identification, faster enrollment, and better retention—driven by RWD—come in.
Step 1: Redefine Site Identification with Data, Not Guesswork
Traditionally, site identification has relied on familiarity and past performance, an approach ill-suited to today’s rapidly evolving healthcare landscape. Over-reliance on high-performing sites causes fatigue, slows enrollment, and limits diversity. Meanwhile, underserved areas with viable patient populations go untapped.
The solution? RWD-powered, patient-centric site identification. By analyzing de-identified electronic health records (EHRs), sponsors can locate where qualifying patients already receive care and activate those sites first.
Key tactics include:
- Precision Cohort Identification: Use filters like demographics, diagnoses, procedures, medications, and labs to align real-world patients with protocol criteria.
- Patient-First Site Strategy: Begin with community and research-driven sites where patients already receive care, expanding to academic centers for broader reach.
- Diversity by Design: Tap RWD to identify and include underrepresented populations, promoting more inclusive trials.
- Smart Activation: Evaluate real-time data on staffing, startup speed, and infrastructure to prioritize sites ready to enroll efficiently.
This data-driven approach boosts activation speed, enhances enrollment, and improves patient representation.
Step 2: Revolutionize Patient Recruitment and Retention
Even with the right sites, recruiting qualified patients is a persistent challenge. Traditional methods like ads and social media often yield unqualified leads, overwhelming site staff and inflating costs.
But the bigger issue? Dropout. Nearly 30% of participants leave mid-trial; 90% due to preventable issues like logistical burdens or disengagement.
The answer: smarter recruitment, fueled by RWD, AI, and patient-focused tools.
Effective strategies include:
- Federated Networks: Conduct real-time, privacy-compliant searches across healthcare organizations, adhering to the Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR).
- Artificial Intelligence (AI) and Predictive Analytics: Identify potential participants early by analyzing longitudinal health data.
- Digital Waiting Rooms: Track near-eligible patients for timely enrollment.
- Interactive Dashboards: Monitor enrollment, engagement, missed visits, and protocol adherence.
- Hybrid Trial Models: Use telehealth and remote monitoring to reduce burdens and expand access.
- Engagement Apps: Offer mobile tools for reminders, education, and progress tracking.
Combining clinical insight with tech-enabled convenience dramatically improves both recruitment and retention.
Step 3: Learn from the Front Lines
Leading organizations are already seeing results from these approaches.
Case in Point: Advancing Lupus Trials Through RWD and AI
A leading academic medical center in the U.S. faced an uphill battle in enrolling patients for lupus trials. With strict criteria and a highly specific population, the odds were stacked against success. By working with TriNetX’s federated RWD, leveraging AI, and enhancing patient engagement, the research team was able to overcome recruitment challenges. This proactive model is helping to ensure that groundbreaking lupus treatments reach those who need them most.
Another Win: Accelerating Myeloma Research Through Data-Driven Recruitment
A research team sought to overcome recruitment delays and inefficiencies in myeloma trials caused by manual patient identification. By adopting a patient-centric, data-driven approach and leveraging TriNetX’s tool to rapidly identify and recruit eligible patients into clinical trials, they significantly improved screening efficiency and expanded access to studies, including rare disease cohorts. This transformation has accelerated enrollment timelines, enhanced trial feasibility, and ensured that more patients benefit from cutting-edge treatments.
The Future Is Federated, Predictive, and Patient-First
The last mile may be the most complex stage of a clinical trial, but it’s also where the most transformative innovations are possible. RWD, paired with intelligent tools and patient-first strategies, empowers clinical teams to reduce timelines, control costs, and improve access to life-changing therapies.
About Justin North
Over the last decade, Justin has led dozens of software solutions from idea to commercial release with companies including Phillips Healthcare, goBalto, and Oracle. He brings a deep background in data science and clinical research to his role as Director of Product Management at TriNetX, where he has overseen the development of products for trial design and feasibility.
