A Roadmap for Engaging Emerging Sites and Investigators in Clinical Research

Clinical trials are struggling to enroll enough patients—80 percent fail to meet enrollment targets on time, and 37 percent of sites under-enroll. Part of the problem is geographic: Trial sites cluster around major academic medical centers, leaving many communities without access to research participation. But the gap also reflects a lack of visibility and connectivity between emerging sites and sponsors, and sponsor processes that default to familiar, established partners. Emerging, community-based sites are part of the solution. But the path into clinical research is highly regulated and process-driven, and most existing guidance is written for sponsors or established sites—not for organizations just entering the field.

This roadmap maps the full site engagement life cycle—from readiness and site selection through study start-up, execution, and performance evaluation—to identify where the burden on emerging sites is highest and what sponsors and sites can do about it.

Inside, you'll find:

• a five-phase framework for engaging emerging sites, with practical guidance at each stage;
• existing tools and resources relevant to each phase; and
• gaps in the current ecosystem and recommendations for closing them.

The two briefs next to the "Download Report" button: 

• Is Clinical Research Right for You? A Brief for Emerging Site Leadership: Distills the roadmap’s guidance for executive decision-makers at emerging sites weighing whether and how to enter clinical research.
• The Case for Working with Emerging Sites: A Brief for Sponsor Leadership: Makes the case to sponsor leadership that engaging emerging sites is a structural fix for enrollment challenges, with a practice-by-practice breakdown of barriers and solutions.