ADVANCING CELL THERAPY SAFETY WITH REAL‑WORLD DATA: FROM SIGNAL DETECTION TO PROACTIVE RISK MITIGATION

Purpose of RWD: Extend safety surveillance beyond trials to diverse, real‑world populations and care settings across the cell therapy lifecycle. 

Signal Detection: Improve early identification of rare, delayed, and context‑specific toxicities using fit‑for‑purpose cohorts and advanced analytics (e.g., NLP, temporal methods). 

Benefit–Risk Assessment: Strengthen evidence with external comparators and longitudinal outcomes, enabling credible, subgroup‑aware evaluations. 

Proactive Mitigation: Translate insights into risk models and learning‑health‑system feedback loops to optimize patient selection, monitoring, and intervention pathways. 

Data Quality and Methods: Ensure completeness, timeliness, provenance, standardized terminologies, prespecified protocols, confounding control, and sensitivity analyses. 

Regulatory Alignment: Meet expectations for fit‑for‑purpose sources, traceable and reproducible methods, and early engagement aligned to RWD/RWE, pharmacovigilance, and PASS guidance.