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Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators' perspective.

Abstract
Clinical 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.
AuthorsSindhu Sivanandan, Kajal Jain, Nishad Plakkal, Monika Bahl, Tanushree Sahoo, Shirshendu Mukherjee, Yogendra Kumar Gupta, Ramesh Agarwal
JournalJournal of perinatology : official journal of the California Perinatal Association (J Perinatol) Vol. 39 Issue Suppl 1 Pg. 20-30 (09 2019) ISSN: 1476-5543 [Electronic] United States
PMID31485015 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Biological Products
  • Pulmonary Surfactants
  • beractant
Topics
  • Animals
  • Biological Products (therapeutic use)
  • Drug Approval (legislation & jurisprudence)
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Goats
  • Government Regulation
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Male
  • Pulmonary Surfactants (therapeutic use)
  • Randomized Controlled Trials as Topic (ethics, legislation & jurisprudence, methods, standards)
  • Research Design
  • Research Support as Topic
  • Respiratory Distress Syndrome, Newborn (drug therapy)
  • Third-Party Consent

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