Review of Pediatric Otolaryngology Clinical Trials: Past Trends and Future Opportunities.

OBJECTIVES/HYPOTHESIS: Pediatric otolaryngologic conditions are highly prevalent in the United States. Although data gathered from clinical trials drive therapeutic strategies, the trends of research in pediatric otolaryngology remain unclear. The objective of this study was to characterize recent trials in pediatric otolaryngology to better understand current directions of study and to identify opportunities for future research.

STUDY DESIGN

Retrospective analysis.

METHODS

A retrospective analysis of United States pediatric clinical trials in otolaryngology between 2001 and 2017 was conducted on ClinicalTrials.gov. Criteria for inclusion included otolaryngologic trials with at least one trial arm of participants <18 years of age, interventional design that was closed, and conducted in the United States. We assessed the information available to us on ClinicalTrials.gov to identify recent trends in pediatric otolaryngology interventional research. We used PubMed to examine publication rates and National Institutes of Health RePORTER to characterize funding patterns for these trials.

RESULTS

Of the 122 trials analyzed, 25% investigated treatments for rhinitis, 25% for acute otitis media, and 50% for all other conditions. Drug studies comprised 72% of all trials. Overall, 65% had their results published in a peer-reviewed journal. Industry funding accounted for 73% of financial support.

CONCLUSIONS

Continued focus on the development of pediatric otolaryngologic clinical trials allows an opportunity to better represent the wide spectrum of disease and therapy in the specialty. Increasing the rates of results publication and federal funding may spearhead a more balanced landscape of clinical trials and further advance the care of children with otolaryngologic disease.

LEVEL OF EVIDENCE

NA Laryngoscope, 130:2719-2724, 2020.