Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

Despite numerous pediatric legislative initiatives worldwide, neonates are largely treated with medicines that have not been specifically approved or indicated for this population.1-5 Some of the reasons cited for why so few products have been developed for neonates include gaps in understanding complex pathophysiology, a small market with unique conditions, challenges in the design and execution of clinical trials, and difficulties with the assessment of safety and efficacy. Evaluation of drug safety in neonates is frequently complicated by exposure to multiple drugs, high rates of comorbidities, and complex assessments of short- and long-term outcomes.

Source: The Journal of Pediatrics - November 6, 2019 Category: Pediatrics Authors: Jonathan M. Davis, Gerri R. Baer, Susan McCune, Agnes Klein, Junko Sato, Laura Fabbri, Alexandra Mangili, Mary A. Short, Susan Tansey, Barry Mangum, Isamu Hokuto, Hidefumi Nakamura, Thomas Salaets, Karel Allegaert, Lynne Yao, Michael Blum, Joseph Toerner, Tags: Commentary Source Type: research