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Pediatric Otolaryngologic Clinical Trial Patterns Underscore Increased Representation Opportunities

by Linda Kossoff •

What do recent trials in pediatric otolaryngology indicate regarding the direction of study in the field and future research opportunities?

BOTTOM LINE: Continued focus on pediatric otolaryngologic clinical trials enables improved representation of the specialty’s spectrum of disease and therapy, while increased results publication and federal funding may advance patient care.

BACKGROUND: Although otolaryngological diseases are prevalent in the U.S. pediatric population, the treatments and surgeries often used to manage them increase the societal and personal health burden. Underreporting of pediatric otolaryngology clinical trial details contributes to inefficiencies in therapy development.

STUDY DESIGN: Retrospective analysis.

SETTING: Department of Otolaryngology–Head and Neck Surgery, School of Medicine, Boston University, Boston.

SYNOPSIS: Researchers obtained information on 122 pediatric otolaryngology clinical trials conducted between 2001 and 2017 in the U.S. to assess the information and identify recent trends in pediatric otolaryngology interventional research. They identified rhinitis, acute otitis media, adenotonsillectomy, myringotomy, and obstructive sleep apnea as the five most commonly studied pediatric otolaryngologic conditions. The most common interventions for pediatric otolaryngologic conditions were devices and behavior for hearing loss, procedures for intubation and ankyloglossia, and drugs for all other pathologies. The majority of pediatric otolaryngologic trials were funded by industry, which may be a factor in setting research direction. Funding patterns showed strong governmental support for some conditions, such as hearing loss. In comparing the relatively small number of pediatric trials to the numerous adult otolaryngologic studies performed over the same period, researchers cite more stringent criteria, lack of infrastructure, and the relative absence of disease as likely barriers. However, continued focus on the development of these trials presents opportunities for improved representation in the specialty. Study limitations included potentially inaccurate or incomplete data and the absence of a placebo group.

CITATION: Shetty KR, Komshian SR, Devaiah A, Levi JR. Review of pediatric otolaryngology clinical trials: past trends and future opportunities [published online ahead of print January 29, 2020]. Laryngoscope. doi:10.1002/lary.28511.