How Vaccine Trials Could be Affected by Potential Policy Changes

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: US Health and Human Services Secretary Robert F. Kennedy Jr. recently commented on supporting placebo-controlled trials for all new vaccines. How could a potential policy shift in this area affect trial design and timelines?

Kong: First, it's important to clarify that placebo-controlled trials are already the gold standard in vaccine development, and are required by both the FDA and EMA when no approved alternatives exist. Therefore, the notion that these aren't already in use is misleading, or at least lacks context. Now, if a policy shift were to mandate placebo use in all vaccine trials, even where active competitors might be more appropriate, we'd likely see significant impacts on both design complexity and timelines. First, ethics boards may push back. If an effective vaccine already exists, withholding it in favor of placebo could be viewed as unethical. This leads to delays, extra review cycles, and potential public concern. Next, placebo-controlled designs often require longer follow ups, which can prolong timelines by months or even years. Lastly, these designs are frequently more difficult to recruit for, patients and parents may be reluctant to participate if there's a genuine chance of receiving no active protection. If policy does shift, having tools that can adapt trial design without compromising data integrity or patient trust will be essential.