At the Veeva R&D and Quality Summit in Boston, we interviewed Dr. Christina Brennan, Senior Vice President of Clinical Research at Northwell Health, on the persistent challenges and future of site operations.
Dr. Brennan highlighted patient recruitment as the most enduring bottleneck in clinical trials, noting that while 80% of participants come from known patient populations, sites still struggle to identify and enroll them efficiently. She emphasized the role of technology—particularly AI and natural language processing applied to electronic health records—in accurately matching patients to complex eligibility criteria beyond diagnosis codes.
The discussion also highlighted the need for sponsors to engage more effectively with sites in protocol design. Brennan advocated for revisiting practices such as running mock patients through assessment schedules and reinstituting investigator meetings that once drove meaningful protocol amendments. She warned that protocols misaligned with the standard of care increase deviations and place coordinators in untenable positions.
Regarding workforce dynamics, Brennan noted that coordinators frequently face high training demands, technology overload, and burnout. She called for workload acuity tools to fairly balance trial assignments and for sponsors to recognize coordinators’ input as critical to trial success.
Looking ahead, Brennan envisioned stronger site–sponsor partnerships rooted in clear communication and accountability. While AI tools may eventually support real-time guidance, she stressed that human oversight remains indispensable to protect patients and ensure protocol compliance.
This post is sponsored by Veeva Systems
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
