Publications by authors named "Victoria DiBiaso"
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 Victoria DiBiaso
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.
Since its commencement as part of the Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA) V in 2012, patient-focused drug development (PFDD) has become an integral part of the drug development paradigm. FDA encourages the development and use of Patient-Experience Data (PED) as it provides important information on the patients' needs and perspectives and inform regulatory decision-making. While the FDA is required to fill out a table which includes a list of various types of Patient Experience Data (PED) and if such data was reviewed by FDA as part of a drug application, there is still a need to understand how FDA uses PED in its regulatory decision-making.
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