In vaccine clinical trials, tracking participant safety is non-negotiable. Unlike drug trials, vaccine clinical trials involve healthy volunteers, making real-time monitoring of adverse events (AEs) crucial. However, many trials face challenges with delayed reporting, missed safety data, and compliance risks, potentially compromising trial outcomes.
Why Is Safety Tracking So Challenging in Vaccine Clinical Trials?
In our previous webinar, Tracking Participant Safety in Vaccine Clinical Trials, held on March 7, Dr. Jose Jimeno, CEO of Vaxtrials (Emmes Group), mentioned that:
“Vaccine trials rely on two critical components: sample management for immunogenicity or efficacy and safety reports for regulatory compliance. While trained professionals handle the first, safety data depends on participants, who may not always report symptoms accurately or promptly.
Adverse events can occur at any time, and since safety results are based on voluntary reports of healthy volunteers, reporting AEs is not part of their routine. Without automated reminders and real-time tracking, critical data is often missed, leading to protocol deviations.”
A relevant aspect mentioned by Dr. Jimeno, also refers to:
“Failure to meet protocol objectives related to safety or outcomes can significantly impact trial results. This is especially critical in large-scale trials, where research sites are managing high enrollment numbers, large sample volumes, vaccine administration, and multiple concurrent activities—making it even harder to track safety data effectively.”
What Takes Place If Safety Tracking Doesn't Work?
Missed safety data can compromise study results and results in unmet trial objectives. The following are some of the main dangers of inadequate safety monitoring:
- Data collection that is fragmented and delayed: Safety tracking becomes irregular and delayed when participants report adverse events (AEs) via paper forms, emails, or phone calls, resulting in reporting gaps.
- Higher dropout rates: A convoluted or inconvenient AE reporting procedure deters participation and raises the risk of dropouts.
- Lack of follow-up: As Dr. Jimeno noted during our webinar, participants who do not communicate with research sites at least once a month run the risk of losing touch because their phone numbers may change, they may move, or they may become disengaged.
How Can Safety Tracking Be Improved by Technology?
A specific ePRO system is needed for vaccine clinical trials, but not all ePROs are equal. These vaccine clinical trials require automation, simplicity, and quick implementation to keep up with large-scale studies. The ideal ePRO solution ought to provide:
- A library of pre-built symptoms for consistent reporting cohort, and dependency setup.
- Automated data gathering to guarantee that no vital safety incident is overlooked.
The Distinctive Features of TrialPal
The only ePRO created specifically for vaccine trials is TrialPal, which offers a highly customizable, automated, and structured system for tracking safety and efficacy.
- Made for diverse populations and healthy volunteers, TrialPal facilitates community-based research and household-level reporting (parents reporting for children, for example) to ensure greater participant coverage.
- Automated reminders and real-time notifications ensure no adverse event is overlooked, keeping sponsors and sites informed.
- Offline functionality: To ensure consistent data collection in any environment, participants can report symptoms even if they are not connected to the internet.
- Centralized dashboards: For better decision-making, sites, sponsors, and CROs have immediate access to real-time safety and efficacy data.
In our most recent webinar, Dr. Jimeno, who helped create TrialPal, emphasized its significance:
“After noticing persistent problems with paper diary reporting, we developed TrialPal. We update the platform daily to reflect emerging design, technology, and patient engagement trends—but always with a vaccine-focused mindset.”
Case Study of a Vaccine Clinical Trial
Dr. Jimeno gave a real-world example of a sizeable respiratory virus vaccine trial in which the research team failed to detect essential cases in the initial months of monitoring.
✅The issue? Sites were not allowed to call participants per protocol, and participants were not contacting sites. Thus, early cases were entirely overlooked.
✅ The answer? Four times as many legitimate reported cases were present when an ePRO system was implemented.
While spending hundreds of millions of dollars, a trial with 30,000+ participants usually seek to find fewer than 100 cases over several years. The decision is obvious: investing in a suitable ePRO solution for safety tracking is well worth the money when compared to the cost of losing a single case.
Watch the Webinar to See It in Action!
The recent webinar on “Tracking Participant Safety in Vaccine Clinical Trials” included expert insights, best practices, and real-world examples of how to increase the safety of vaccine trials.
If you missed it to see how technology may improve trial success, safety, and compliance.
