Author:
Sivanandan Sindhu,Jain Kajal,Plakkal Nishad,Bahl Monika,Sahoo Tanushree,Mukherjee Shirshendu,Gupta Yogendra Kumar,Agarwal Ramesh
Abstract
AbstractClinical trials are essential to test the safety and efficacy of new treatments in any population. The paucity of drug trials especially in the neonatal population has led to the widespread use of unlicensed or off-label medications, exposing them to the risks of drug toxicity and ineffective treatment. Ethical and operational challenges are no longer considered valid excuses for not conducting drug trials in neonates. We recently participated in a combined phase-2 and phase-3 trial investigating a new indigenous goat lung surfactant extract (GLSE) for the treatment of respiratory distress syndrome (RDS) in preterm neonates. In this article, we share pertinent challenges faced by us during the trial to better inform and foster-positive discussion among drug developers, administrators, regulatory authorities, patient advocacy groups, and researchers. Also, we provide many tools developed for the GLSE trial that can be modified and used by prospective trialists.
Publisher
Springer Science and Business Media LLC
Subject
Obstetrics and Gynecology,Pediatrics, Perinatology and Child Health
Cited by
14 articles.
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