Clinical trials in otology: Examining trends and framework for prioritization

Area of Science:

• Otolaryngology research
• Clinical trial analysis
• Medical research trends

Background:

• Otologic clinical trials are crucial for advancing treatments for hearing and balance disorders.
• Understanding trends in otologic research is essential for guiding future study design and funding.
• The period from 2008 to 2018 saw significant developments in medical research methodologies and data accessibility.

Purpose of the Study:

• To characterize the landscape of otologic clinical trials registered on ClinicalTrials.gov.
• To identify and analyze trends in otologic clinical trials conducted between 2008 and 2018.
• To provide insights into the focus areas, funding, and outcomes of otologic research.

Main Methods:

• Data extraction from the ClinicalTrials.gov database for otology-focused trials from 2008 to 2018.
• Analysis of trial status, funding sources, specific otologic conditions studied, and overall trends.
• Statistical examination of changes in trial numbers and focus areas over the decade.

Main Results:

• A total of 992 otology clinical trials were identified between 2008 and 2018.
• Industry sponsorship dominated (76.5%), with hearing loss (40.6%), vestibulopathy (18.8%), tinnitus (18.8%), and otitis media (15.1%) being the most studied conditions.
• A significant annual increase of 12.0 trials was observed (p < 0.001), primarily driven by studies on hearing loss and vestibulopathy. Most trials focused on treatment.

Conclusions:

• Otologic clinical trial activity significantly increased from 2008 to 2018, with notable growth in trials for hearing loss and vestibulopathy.
• Industry remains the primary sponsor, and the focus is predominantly on treatment interventions.
• This analysis offers a comprehensive overview of otologic clinical trials, valuable for future research and development in the field.