Publications by authors named "R Adiutori"
Objective: Including qualitative research in clinical trial design is an innovative approach to understanding patients' perspective and incorporate the patient's voice in all stages of drug development and evaluation. This review aims to explore current practices, lessons learned from the literature, as well as how qualitative interviews are considered by health authorities for marketing authorization and reimbursement.
Methods: A targeted literature review of Medline and Embase databases was conducted in February 2022 to identify publications on qualitative methods embedded in clinical trial of pharmaceutical products.
Background: Regulatory guidance advises validation of patient-reported outcome (PRO) instruments prior to use in pivotal clinical studies, which may then be used to generate critical patient-centered evidence and support labelling claims. This targeted literature review aimed to determine if PRO instruments psychometrically validated in a phase 3 trial setting could support label claims from the same phase 3 study (i.e.
View Article and Find Full Text PDFArticle Synopsis
- The study investigates how the plasma proteome—specifically circulating protein aggregates—reflects an organism's inflammatory and metabolic states and serves as a predictor for various organ-specific diseases, especially amyotrophic lateral sclerosis (ALS).
- Using advanced proteomic techniques, researchers compared the protein composition of circulating aggregates from ALS patients and healthy individuals, focusing on the presence of neurofilament proteins associated with brain issues.
- Findings revealed that ALS patient protein aggregates contain proteins related to the proteasome system and exhibit unique aggregation properties, while healthy individuals' proteins are more involved in metabolic functions, highlighting distinct differences in health status and proteostasis.
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
View Article and Find Full Text PDFArticle Synopsis
- * Many of these proteins do not have traditional RNA-binding domains, but specific nucleic acid structures, especially pyrimidine-rich regions, are key to maintaining their solubility.
- * Interestingly, protein aggregates from ALS patients can be returned to a soluble state using RNA or synthetic oligonucleotides, suggesting new approaches to tackle protein aggregation issues.