Clinical trials have traditionally faced significant hurdles in patient recruitment and retention. The current model, which typically requires patients to travel to physical clinical sites, often fails to meet recruitment targets and results in high dropout rates. Statistics reveal that 85% of trials miss their time lines, and in many cases, dropout rates can reach as high as 30%. Compounding these issues is the lack of diversity in trial populations, with less than 15% of participants coming from minority groups, despite these communities often experiencing the most severe disease burden.
Challenges in Patient Recruitment and Retention
Recruitment for clinical trials is one of the most resource-intensive aspects of drug development. The reasons for low recruitment are multifaceted. Geographical constraints limit patient access, especially for those living in rural or underserved areas. Time commitments, travel, and disruptions to daily life are significant barriers for participants, particularly those managing chronic illnesses. These burdens not only reduce initial recruitment but also contribute to the high dropout rates seen in many trials.
The complexity of trial designs and screening assessments and the lack of awareness about clinical trials also exacerbate these challenges. For many minority groups, historical mistrust in the medical system and the lack of outreach efforts further deter participation. These issues combine to make clinical trial recruitment and retention a costly and inefficient process.
How Optimized Trials Address These Challenges
Optimized trials (study designs that incorporate decentralized clinical trial DCT components) offer a flexible, patient-centered approach to clinical research. By blending DCT elements — such as telemedicine visits, electronic consent (eConsent), and home-based care — alongside traditional site-based interactions, optimized trials overcome the logistical and psychological barriers that traditional site-based trials encounter.
Patients can now participate from the comfort of their homes, reducing travel burdens and making it easier for them to adhere to the study protocol. The use of remote monitoring tools, including wearable devices, allows for real-time data collection and reduces the number of in-person visits required. This flexibility is particularly important for recruiting patients who may have limited mobility or who live far from research centers.
Digital Outreach and Recruitment Tools
The industry has seen a significant increase in direct-to-patient recruitment as a core component of study recruitment plans. For traditional models, this can accelerate enrollment, and in DCT studies, it often acts as the primary source of patients enrolled. Digital recruitment campaigns can engage potential participants through social media, online search, and email marketing, reaching a broader demographic and ensuring more diverse participation.
Additionally, once recruited, patients need to feel engaged throughout the study. Optimized trials use communication platforms that provide timely updates, appointment reminders, health education information, and easy access to study teams, keeping patients informed and engaged. This constant interaction reduces dropout rates, as patients feel supported and more likely to stay involved.
Case Studies: Success in Recruitment and Retention
One recent example from Elligo Health Research® showed how optimized trials using digital outreach successfully recruited over 14,000 participants in a hybrid clinical trial across multiple sites and patient populations. The trial, which involved home visits, remote monitoring, and centralized oversight, saw significantly lower dropout rates compared to traditional trials.
Conclusion
Optimized trials represent a patient-centric future for clinical research. By removing geographical barriers and integrating digital tools, these trials provide a flexible, efficient, and more inclusive model of clinical research. As the industry continues to adopt these strategies, we can expect to see higher recruitment and retention rates, more diverse trial populations, and faster drug development time lines.
About Leslie Carney, Patient Recruitment & Marketing, Elligo Health Research
Leslie Carney, MBA, has over 20 years of consumer marketing, relationship management, and sales experience, having started in the nonprofit sector as a fundraiser before joining clinical research in 2017. Leslie joined Elligo in February 2024 as Senior Director, Patient Recruitment and Marketing and is leading the company’s initiatives to accelerate recruitment across Elligo’s site network as well as grow its stand-alone Patient Recruitment and Retention solutions business line for CROs/sponsors.
Prior to Elligo, Leslie was with CVS Clinical Trial Services, where she oversaw enrollment for fully virtual studies and managed local, community-based recruitment for CVS Trial Delivery sites. She has managed recruitment for U.S. sites as well as OUS projects directly for clients, focusing on digital marketing and partnerships to ensure high-volume and rapid enrollment goals are achieved. During her time at IQVIA, Leslie developed bespoke recruitment and retention strategies to remove barriers to enrollment and reduce burden on patients and sites, for traditional site models as well as hybrid and fully virtual study designs.
About Elligo Health Research
Elligo Health Research is a leading integrated research organization that pioneered accelerating clinical trials by embedding research directly into community healthcare settings. This approach transforms research into care, enabling primary physicians to offer clinical trials as part of standard patient care, expanding access to innovative treatments and increasing inclusivity for underserved communities. For trial participants, Elligo also provides comprehensive patient travel services, ensuring accessibility and reducing barriers to participation.
For more information on clinical trial travel solutions, please visit Elligo Health Research.