Publications by authors named "Cristina Llanos"
High-Fidelity Clinical Simulation to Improve a Pediatric Clinical Trial Design: Lessons Learned and Conceptualization of the Return on Investment (ROI) and Return on Engagement (ROE) Analysis.
Jose Maria Quintillá Carmen de la Gala Ruben Berrueco Joana Claverol Bibiana Figueres Cristina Llanos
Paediatr Drugs
November 2024
Article Synopsis
- Clinical trials for pediatric patients are complex, especially with decentralized designs, and high-realistic simulations can help refine processes and improve interactions among professionals, patients, and families.
- This research examined how simulations affected three critical stages of a clinical trial: the initial visit, home drug administration by parents, and pharmacokinetics sample processing by a home nurse.
- The findings showed that while families could administer the drug as required, they faced challenges, and recommendations were provided to enhance safety and patient experience in future trials, highlighting the value of simulation to proactively identify risks and improve protocols before finalization.
We evaluated the administration of ARI-0001 cells (chimeric antigen receptor T cells targeting CD19) in adult and pediatric patients with relapsed/refractory CD19 malignancies. Patients received cyclophosphamide and fludarabine followed by ARI-0001 cells at a dose of 0.4-5 × 10 ARI-0001 cells/kg, initially as a single dose and later split into 3 fractions (10%, 30%, and 60%) with full administration depending on the absence of cytokine release syndrome (CRS).
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