Bridging Clinical Research Gaps: How Site Augmentation Enhances Trial Success

Site augmentation emerges as a dynamic response to the growing complexity and volume of clinical trials, and the challenge of limited resources at clinical research sites. This support model, which is fashioned off of the proven FSP staffing strategy used by pharmaceutical companies and CROs, leverages specialized personnel to support clinical research sites, alleviating operational pressure, enhancing site performance, and enabling faster, more efficient clinical trials.

Clinical research site staff face persistent challenges that threaten trial timelines and outcomes. A recent study from the Tufts Center for the Study of Drug Development (CSDD) highlighted critical pain points, including poor site performance, patient recruitment difficulties, and delays in trial completion. Based on a recent Site Landscape Survey conducted by The Society of Clinical Research Sites (SCRS) nearly 50% of clinical research sites operate with less than three months of working capital. Additionally, staffing turnover continues to hinder site performance, with 53% of sites reporting annual staff turnover rates between 1% and 10%. Another critical finding reveals 80% of clinical trials fail to meet enrollment targets on time, resulting in estimated losses of up to $8 million per day due to delays.

The power of site augmentation

Site augmentation directly addresses these challenges by providing specialized personnel tailored to the unique needs of each clinical site. These professionals can work remotely, on-site, or in a hybrid model, filling gaps in patient-facing and administrative roles. Site augmentation services can be leveraged to support patient recruitment, screening, data management, study coordination, and technical support for trial-specific technologies.

A key benefit of site augmentation is its flexibility. Staff can be deployed when site resources are stretched during periods of high-volume activities or for specific tasks such as patient enrollment drives, long-term follow-up, or technology management. This adaptable resource model allows research sites to focus on quality patient care while more efficiently managing administrative tasks and optimizing successful trial outcomes.

Comprehensive site augmentation services

Site augmentation services encompass a wide range of specialized roles, including patient-facing tasks such as pre-screening, enrollment, study visit activities, patient education and training, and other hands-on support. Administrative and data management tasks include data entry, compliance monitoring, regulatory reporting, technical troubleshooting for devices and portals, study documentation, and audit preparation. Additionally, specialized research roles cover clinical assessments, blood draws, and drug administration, including IV infusions by research nurses or other qualified medical professionals. This resource model ensures that clinical sites can efficiently manage their complex workloads while maintaining high standards of patient care and data integrity.

Is opening more sites the best solution?

Historically, the response to lagging enrollment and/or increased study timelines has been to open additional research sites. However, this approach takes time, adds costly resources, and neglects optimizing the productivity of existing sites. Offering site augmentation to existing high-performing sites maximizes success with flexible resources, rather than spending time and money opening and setting up additional sites or investing in sites struggling with low or even zero patient enrollment.

Proactively including site augmentation in site contracts/grants would save time and build in efficiencies enabling higher productivity to achieve study milestones. By strengthening existing sites, primary investigators are more incentivized to take on new trials regardless of trial complexity and duration.

Choosing the right site augmentation partner

Selecting a qualified site augmentation partner is crucial for success. Experienced providers have a robust infrastructure, skilled personnel, and experience with current technologies that align with clinical trial needs globally. A well-established partner fosters a collaborative environment with both sponsors and sites, providing dedicated team members, streamlining operations and workloads.

The ideal site augmentation partner extends expertise across multiple trial elements, including hands-on patient care, telehealth services, pharmacy services, supply chain management and IT system support, to name a few. This broad experience can facilitate more efficient project startup, and more comprehensive trial management and close-out. Choosing the right partner who has knowledge of the sponsor, the vendors and the site is key to maximizing the return on investment.

Real-world success stories

One notable success story involved a competitive therapeutic area where site augmentation enabled a sponsor to outperform its competitors. Initially, a six-month pilot program was conducted across several countries. The results were immediate and striking. Sites that implemented augmentation services saw a significant increase in patient enrollment, retention, reduced burden of participation and improved satisfaction. This led the sponsor to offer site augmentation globally demonstrating ease of implementation, scalability and enhanced study outcomes.

Site augmentation may be optimal for trials involving high volume or complex clinical activities, multiple technologies, or very competitive therapeutic areas or patient populations.

Innovation through collaboration

Understanding how site augmentation services could be leveraged to overcome challenges is not the responsibility of one entity. The most creative and effective solutions arise from collaboration among all stakeholders — sponsors, CROs, service providers, and research sites — sharing insights, addressing challenges, and building comprehensive support structures. Transparent communication and clearly defined expectations are essential from the outset.

By fostering collaboration, enhancing operational efficiency, and reducing site burden, site augmentation holds the potential to accelerate clinical research, ultimately bringing life-changing therapies to patients faster and more efficiently. A collaborative, results-driven approach can significantly impact the future of clinical trials, ensuring sustainable growth and successful patient outcomes.

Initiate the dialogue around site augmentation today in order to begin building a framework for exchanging ideas, sharing best practices, and driving a more scalable model for sites that positively impacts outcomes for sponsors.

Photo: Blue Planet Studio, Getty Images

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