The Potential for Stricter Regulations 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: How could stricter regulations around vaccine trials affect patient recruitment and retention?

Kong: Stricter regulations tend to increase trial complexity, more eligibility checks, longer consent forms, tighter protocols, and that absolutely impacts both recruitment and retention. The stakes are especially high in vaccine trials. Participants are often healthy volunteers, sometimes children, and they tend to be more cautious. If new regulations make trials feel riskier or more burdensome, we could see significant drop in recruitment. Retention is another concern. Stricter monitoring or rigid visit schedules may feel intrusive or exhausting for participants. That serves as a recipe for mid study dropout, which threatens both trial power and budget, and no one wants that. What's needed is a shift from focusing solely on protocol compliance to truly understanding the human aspect of participation. Why are patients enrolling in the first place? What worries them during the study and when are they most likely to drop out? Behavioral analytical tools can help identify and support at risk participants before they disengage. This kind of foresight is essential if regulations become more demanding and patients more hesitant.