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Methodological Insights on Biomarker-Based Patient Selection: A Review of Scientific Advice Procedures at the European Medicines Agency.
Clin Pharmacol Ther
January 2025
Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, The Netherlands.
Biomarkers play a pivotal role in the selection and enrollment of trial participants. Particularly, predictive biomarkers help tailor medical care to individual patients; however, also prognostic biomarkers require consideration at the design stage. At the time of initiating a clinical trial, there may be uncertainty about whether a biomarker is predictive or prognostic, and the trial design may need to account for this.
View Article and Find Full Text PDFCurrent trends in antimicrobial use and the role of antimicrobial stewardship in palliative oncology: a narrative review.
BMC Palliat Care
January 2025
Division of Infectious Diseases, Department of Internal Medicine, and Center for Infectious Diseases Research, American University of Beirut Medical Center, PO Box 11-0236, Riad , Beirut, 1107 2020, Lebanon.
Background: The overuse of antimicrobials is prevalent in palliative oncology care, with up to 86.9% of terminal cancer patients receiving these agents during end-of-life care. This overutilization stems from recurrent infections due to immunosuppression, malnutrition, and frequent hospitalizations, as well as difficulty differentiating infection-related symptoms from cancer-related complications.
View Article and Find Full Text PDFHepatic adverse events associated with ketamine and esketamine: A population-based disproportionality analysis.
J Affect Disord
January 2025
Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada. Electronic address:
Background And Objective: To determine whether there is disproportionate reporting of hepatobiliary disorders in the United States (US) FDA Adverse Event Reporting System (FAERS) for individuals prescribed ketamine or esketamine.
Design: We identified Medical Dictionary for Regulatory Activities (MedDRA) terms in the FAERS related to hepatobiliary disorders.
Main Measures: Formulations of ketamine and esketamine were evaluated for the proportionality of reporting for each hepatobiliary disorder parameter using the reporting odds ratio (ROR).
A conceptual model for advanced/metastatic gastric or gastroesophageal junction cancer: a review of qualitative studies and results from patient interviews.
BMC Cancer
January 2025
Patient Centered Solutions, IQVIA, Reading, UK.
Background: Despite approvals of new first-line immunotherapies for advanced/metastatic gastric cancer/gastroesophageal junction cancer (aGC/GEJC), patients' median survival is around 14 months and their health-related quality of life (HRQoL) is affected by disease-related symptoms and treatment-related side effects. Using a targeted literature review (TLR) and patient interviews, this study identified disease- and treatment-related concepts that are important to patients with aGC/GEJC and their HRQoL.
Methods: A TLR was conducted to identify primary qualitative studies from 2018 to 2021 on patients' experiences with aGC/GEJC.
Prolactin-induced sensitization of trigeminal nociceptors promotes migraine co-morbidity in endometriosis.
Cephalalgia
January 2025
Department of Pharmacology, University of Arizona College of Medicine, Tucson, AZ, USA.
Background: Women with endometriosis are more likely to have migraine. The mechanisms underlying this co-morbidity are unknown. Prolactin, a neurohormone secreted and released into circulation from the anterior pituitary, can sensitize sensory neurons from female, but not male, rodents, monkeys and human donors.
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