A vital part of pharmaceutical manufacturers gaining approval for use by the U.S. Food and Drug Administration are clinical drug trials.

Throughout the years, the federal government has created legislation in an attempt to gather more information on the medications prescribed for children; the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act were made permanent by Congress in August 2012. These types of legislation have led to over 400 pediatric drug-labeling changes since 1998. Because neonates were addressed in only 6% of these changes, they continue to be at risk for receiving ineffective medications, incorrect dosages, and developing unanticipated complications. Although these new laws now include a requirement that pharmaceutical manufacturers submit plans for pediatric studies at certain times in the drug-approval process (e.g., Phase 2), they do not require a neonatal inclusion. This is important because drawing conclusions from the results of drug trials in older children and applying them to neonates is not ideal and continues to leave this population at risk.
Indisputably, unstudied medications for neonates have played a major role in the positive outcomes and increased viability for infants born prematurely, and, overall, recent laws have resulted in great strides in pediatric trials. However, the neonatal population still lags in inclusion. Of over 120,000 studies at the National Institutes of Health clinical trials repository, only 0.6% involves neonates; in total, only 3.4% of all registered pediatric studies involve neonates. Open communication and cooperative sharing between industry and academics are integral components to ensuring that drugs are safe and effective for all populations. According to the first author of the article, Jason R. Wiles MD, "Inclusion of neonatologists and neonatal pharmacologists in study designs, and early in the drug development process, would make data generated from such studies more relevant and useful."
Source-Eurekalert