Current Areas of Focus for Clinical Operations Professionals in Vaccine Trials

In a recent video interview with Applied Clinical Trials, Krinx Kong, chief commercial officer, Cognivia, discussed the potential impacts of policy shifts on vaccine trial design and patient perceptions. Stricter regulations could increase trial complexity, affecting recruitment and retention. Kong emphasized behavioral insights as crucial to understanding patient motivation and mitigating dropouts. Looking forward with the potential for policy changes in vaccine trials, clinical operations professionals must focus on flexibility, behavioral visibility, and effective communication to ensure success.

ACT: Looking forward with the potential for policy changes, what should clinical operations professionals involved in vaccine trials be keeping top of mind?

Kong: Clinical operations professionals are the backbone. They're the unsung heroes of successful trials, and they're also the first to feel the effects of regulatory change. If vaccine policy continues evolving, clinical ops leaders must focus on three key areas. First, flexibility. Build trial designs that can adapt to new data, new regs, or even public sentiment, that includes modular protocols and contingency plans for recruitment or site engagement. Second, behavioral visibility, it's not enough to track visits, check a box, or lab results. Ops teams must understand the psychological journey of participants, when they're likely to disengage, how they interpret study expectations, and what motivates them to stay. Third, communication. Clear, trust building messaging is essential, not just the participants, but also the site staff, to regulators, and the public. Clinical teams must be equipped with predictive tools to monitor adherence, risk, dropout likelihood, and placebo response all in real time. I know that's asking for a lot, but in summary, to my fellow ops family, be agile, be human centered, and be proactive. Vaccine trials are not just scientific, they're social, and the teams that understand both sides will be the ones who thrive in the next phase of clinical research.