Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10655264 | PMC |
| http://dx.doi.org/10.3389/frobt.2023.1232215 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Editorial comment on "Immunomodulatory metabolites in IgE-mediated food allergy and oral immunotherapy outcomes based on metabolomic profiling".
Pediatr Allergy Immunol
January 2025
Pediatric Allergy Unit, Department of Pediatrics, Gynecology and Obstetrics, University Hospitals of Geneva, Geneva, Switzerland.
Editorial: Multi-omics approaches in the study of human disease mechanisms.
Front Bioinform
January 2025
Department of Law, Economics and Social Sciences, University Magna Græcia, Catanzaro, Italy.
Gaps in the ethical governance of pharmaceutical clinical trials in Europe.
Front Med (Lausanne)
January 2025
Gispen4Regulatory Science Consultancy, Bilthoven, Netherlands.
The ethical governance of pharmaceutical clinical trials in Europe, particularly under Regulation 536/2014, is intended to ensure the safety, rights, and well-being of participants. Despite this regulatory framework, significant gaps in ethical oversight remain. This paper identifies five key deficiencies: (1) European regulations only partially address ethical imperatives set by international guidelines, thereby restricting the ethical mandate of relevant entities; (2) the role of research ethics committees is largely limited to pre-approval activities, reducing continuous oversight during trials; (3) GCP inspectors operate within a narrow scope regarding ethical oversight, which limits their ability to identify a broad range of unethical practices; (4) there is insufficient transparency and collaboration between RECs and regulators, specifically GCP inspectorates, leading to fragmented oversight; and (5) there is minimal integration of ethical findings into the marketing authorization decision process by entities such as clinical assessors and the CHMP.
View Article and Find Full Text PDFPredictors of irritability in pediatric autistic populations: a scoping review.
Front Child Adolesc Psychiatry
July 2024
Institute of Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
Introduction: Autism is characterized by social communication differences and repetitive behaviors, affecting 1%-2% of children. Irritability is a disabling condition affecting 19%-80% of autistic children. While extensive research has focused on interventions to reduce irritability symptoms, the underlying correlates remain poorly understood.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!