“In vaccine clinical trials, missing safety data in daily collection creates challenges in reporting safety outcomes to the agencies”. This was one of the key takeaways from our latest webinar on safety tracking in vaccine trials.
What is the result of poor tracking in vaccine clinical trials?
Missed cases or adverse events | Lost efficacy data | Potential regulatory setbacks.
So, how can vaccine trials ensure timely, accurate, and structured safety tracking without adding complexity for sites and participants? In this blog, we will explore the solution and best practices.
Why Real-Time Safety Tracking Matters for Vaccine Trials
Regulatory agencies like the FDA, EMA, and MHRA require precise safety data collection to assess long-term safety outcomes (reactogenicity) and adverse events. Yet, many vaccine trials still rely on outdated methods like paper diaries, phone calls, and scattered reports —leading to:
Data Fragmentation: Participants using paper forms, emails, or phone calls to report symptoms create inconsistencies and delays in analysis.
Compliance Risks: Missing or incomplete data can compromise trial integrity and regulatory approvals.
Real-World Case Study
Ensuring consistent, real-time data collection is one of the biggest hurdles in vaccine research. Svetlana, one of our speakers, shared an interesting personal experience:
Svetlana Rayner, one of our webinar speakers, shared a compelling example:
In a Norovirus vaccine trial, principal investigators (PIs) tracked Adverse Gastrointestinal Events (AGEs) to determine whether a baby had contracted Norovirus. Parents reported symptoms like diarrhea and vomiting.
Using TrialPal, the only ePRO designed specifically for vaccine clinical trials, the system automatically flagged cases where both symptoms were present—strongly indicating Norovirus infection. Out of 1,500 participants, only 30 tested positive.
With such a few positive cases, the question arises: Is the investment in ePRO justified?
According to Svetlana, the answer is a resounding yes. Without daily adverse event (AE) reports, efficacy tracking is compromised, making it challenging to assess vaccine effectiveness—especially in trials with low incidence rates.
Best Practices for Optimizing Safety Tracking in Vaccine Trials
How can sponsors and CROs ensure accurate, real-time participant safety tracking while improving overall efficacy in vaccine clinical trials?
✅ Train Participants on Reporting Tools
A well-trained participant is more likely to report symptoms accurately and on time. Interactive video tutorials on sample collection or AE reporting can improve adherence.
✅ Give Principal Investigators (PIs) Access to Live eDiaries
Allowing PIs to review real-time participant reports helps them make faster, informed safety decisions and address potential issues immediately.
✅ Implement an ePRO from Phase 1
Starting with an electronic patient-reported outcomes (ePRO) system in Phase 1 ensures data consistency across Phase 2 and Phase 3—avoiding biases in reporting that arise from shifting from paper to digital later.
✅ Use Technology to Improve Data Quality
With the right ePRO, such as TrialPal, data entry errors can be minimized by setting limits and alerts and preventing typos. If you can measure it, you can control it.
✅ Enable Household-Level Reporting
Vaccine trials often involve multiple participants from the same household. The ability to track family-wide health outcomes, behavior, and quality of life (QoL) metrics adds greater depth to vaccine efficacy studies.
✅ Ensure Offline Functionality for Remote Areas
Data must be captured on time in vaccine trials—especially when working with healthy populations. Unlike drug trials, where patients are highly engaged due to ongoing treatments, vaccine trial participants may forget to report symptoms unless prompted. An offline-capable ePRO ensures data is captured without an internet connection, reducing missed reports.
The Right ePRO Can Make All the Difference
With TrialPal, vaccine clinical trials can achieve:
- Faster implementation: A prebuilt symptom library and easy rule setup allow rapid deployment.
- More accurate safety and efficacy tracking: Real-time notifications, automated reminders, and data validation prevent errors and delays.
- Better accessibility: Offline functionality ensures reporting from any location at any time.
Tracking participant safety in real-time is no longer optional—it’s a critical factor in ensuring efficacy in vaccine clinical trials. Want to see how TrialPal can improve safety reporting and compliance in your next vaccine clinical trial?
Watch the full webinar recording [here] and schedule a demo today!
