The landscape of clinical trial management is evolving, with site engagement emerging as a critical factor in trial success. At the Outsourcing in Clinical Trials West Coast 2025 conference, industry leaders addressed the growing challenges of managing clinical trial sites and outlined strategic approaches for better engagement.
Post-Pandemic Challenges in Site Management
Clinical trial sites are facing unprecedented challenges in the post-COVID era. Leesa Gentry, Chief Clinical Officer at RenovoRx, highlighted how reduced staffing levels since the pandemic have significantly increased the burden on remaining investigators. "Site staff burnout and understaffing is rampant. Staff have very little time and very little support, [and] we are giving them a protocol that's three times more complex than it was five years ago," Gentry explained.
Protocol Complexity and Resource Constraints
The current clinical trial environment reflects a delicate balance between comprehensive data collection and operational feasibility. Sponsors are attempting to maximize the value of each trial, often resulting in more complex protocols. "We have to throw everything into that protocol to make sure that we're answering all the questions we can with one study, because who knows if we're going to get to do another one," Gentry noted.
Strategic Approaches to Site Engagement
Gentry outlined three fundamental principles for improving site relationships:
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Realistic Expectations: Sponsors must carefully evaluate site enrollment projections, considering potential barriers in eligibility and consent processes. Setting achievable goals from the outset is crucial for successful trial execution.
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Responsive Communication: "Get all the right people on the phone if there needs to be a discussion – be responsive, make sure that you are responding to sites faster than they are responding to you because they will match your energy," advised Gentry.
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Transparent Operations: Clear communication about study requirements, budgets, and expectations helps build trust and efficiency in site relationships.
Technology Integration and Resource Allocation
While technological advances offer potential benefits, their implementation must be carefully considered. Gentry emphasized the importance of efficient technology use, stating, "We need to use it in a way that makes sense." This approach helps prevent additional burden on already stretched site resources.
Practical Solutions for Sponsors
To become a "sponsor of choice," organizations should:
- Maintain rapid response times to site inquiries
- Establish reasonable budgets aligned with site capabilities
- Provide clear explanations when sites are not selected for studies
- Balance global standardization with local site needs
- Actively seek and incorporate site and patient feedback
Despite these best practices, Gentry acknowledged that some challenges might persist: "There are some sites that are not going to enrol and are not going to perform. Some sites will remain difficult to work with." The key is to identify these situations early and adjust strategies accordingly.
Moving Forward
The success of clinical trials increasingly depends on strong site relationships and efficient resource management. By implementing these engagement strategies, sponsors can better support sites while achieving their research objectives, ultimately benefiting the entire clinical research ecosystem.
