Deficiencies in the conduct and reporting of pediatric clinical trials

Abstract

Deficiencies in the conduct and reporting of pediatric clinical trials We read with interest the report by Gates et al evaluating deficiencies in the conduct and reporting of randomized, controlled trials in pediatrics. 1 This work appropriately calls attention to limitations in pediatric research related to study design and selective reporting that negatively impact the quality of available evidence. Whether one uses the medical literature to gather information for direct patient care, guideline development, or health policy decision making, it is critical that the evidence be both sound and robust. Our editors routinely perform detailed literature searches to develop care guidelines in strict accordance with the principles of evidence-based medicine. We performed a survey of completed phase III randomized controlled trials for pediatric oncology using ClinicalTrials.gov; of 10 intervention trials that were correctly indexed as phase III randomized controlled trials with completion dates between 2004 and 2016, we were unable to locate peer-reviewed publication of the results of 8 of 10 of the trials using PubMed. This mirrored our past experience searching for peer-reviewed evidence of the pediatric oncology literature. We applaud the sentiments of Marušić and Pranić in their commentary on Gates; an "emphasis on critical appraisal and understanding of evidence" is likely to lead both to better patient care and better research. 2 Improving the quality of healthcare while bending its cost curve depends on having access to high-quality evidence. Our patients and trial participants deserve no less.