C. Brooke Adams, PharmD, BCOP, discusses the evolving diagnostic criteria and management strategies for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in CAR T-cell therapy, highlighting advances in toxicity prevention and treatment selection.
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The expanding role of real-world evidence in regulatory and health technology assessment (HTA) decision-making highlights its growing acceptance for supplementing clinical trial data, addressing evidence gaps, and informing treatment value, despite challenges in data quality, accessibility, and regulatory compliance.
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