Dora Vallejo – Ardila, Senior Medical Monitor/ Clinical Research Physician at Avance Clinical, shared a post on LinkedIn:
“Safety Signal Detection in Early Oncology Trials: Why It’s Central to ICH E6(R3) Risk-Based Monitoring
As targeted therapies and immuno-oncology agents continue to reshape cancer treatment, early phase trials are now tackling unprecedented complexity and risk. But how do we ensure patient safety without slowing down innovation?
In early trials, a ‘safety-signal’ may indicate a new or changed risk-such as unexpected organ toxicity, delayed immune-mediated events, or dose-limiting side effects—not previously observed. In oncology, where therapeutic windows can be narrow, early identification is key to protecting patients and improving trial success.
What’s changing under ICH E6(R3)?
E6(R3) reinforces a dynamic, proactive approach to clinical oversight, including:
- Real-time, centralized review of safety data
- Defined thresholds for escalation or intervention
- Oversight committees that integrate emerging data into decisions
- Adaptive monitoring based on actual risk and variability, not routine box-checking
Australia’s early phase units are at the forefront of innovation in targeted therapies. Observational data (e.g. from HER2+ therapy cohorts) have already highlighted how real-world safety profiles can diverge from trial assumptions—especially in older or co-morbid patients.
Plus, guidance from the TGA and NHMRC supports embedding RBM and signal detection into clinical trial frameworks—from protocol design to data surveillance dashboards.
Takeaway:
As we adopt ICH E6(R3), sponsors, investigators, and trial sites must treat safety signal detection not as a reporting exercise—but as an essential continuous process for safeguarding patients and ensuring data quality. This is particularly true in early oncology, where every signal counts.
Let’s keep advancing our capabilities in safety oversight—because patients deserve precision not just in therapy, but in protection.”
More posts featuring Dora Vallejo – Ardila.