Measuring Clinical Benefit in Neonatal Randomized Clinical Trials: Challenges and Opportunities
Many of the therapeutics commonly used in neonatal intensive care units (NICU) are not specifically labeled or approved for use in neonates (ie, defined as infants less than 28 days of life, or less than 28 days corrected age for preterm infants).a As such, clinicians lack critical safety and efficacy information on the use of medical products to treat neonatal conditions. Additionally, neonatal-specific medical conditions frequently lack safe and effective treatments, resulting in an unmet need for drug development.
Source: The Journal of Pediatrics - Category: Pediatrics Authors: An N. Massaro, Beth Boyer, Mira Gill, Dure Kim, Matthew Laughon, Michele Walsh, Monica E. Lemmon, Betsy Pilon, Gerri Baer, Duke-Margolis/FDA Measuring Clinical Benefit in Neonatal RCTs Workshop Participants Tags: Workshop/Symposium Summary Source Type: research