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Pediatric Acute Otitis Media Clinical Trials: An Analysis of Diversity
Iman S Iqbal1, Elizabeth M Puyo1, Jonathan M Carnino1
1Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA.
Insights
Pediatric acute otitis media (AOM) trials show significant underrepresentation of diverse populations, with most participants being white. This highlights critical gaps in inclusivity for AOM research.
Area of Science:
- Pediatric clinical research
- Clinical trial diversity and equity
- Acute otitis media (AOM) epidemiology
Background:
- Clinical trials for pediatric acute otitis media (AOM) are crucial for developing effective treatments.
- Ensuring diverse participant representation in AOM studies is essential for generalizability and equitable healthcare.
- Existing guidelines for demographic reporting in clinical trials have not fully addressed inclusivity gaps.
Purpose of the Study:
- To assess the diversity and equity of pediatric acute otitis media (AOM) trials registered on ClinicalTrials.gov.
- To identify demographic representation gaps in AOM clinical trials.
- To inform strategies for enhancing inclusivity in future pediatric AOM research.
Main Methods:
- Retrospective analysis of completed pediatric AOM clinical trials with reported results on ClinicalTrials.gov.
- Analysis of 48 unique trials focusing on participant demographics (age, sex, race, ethnicity) and trial characteristics (location, sponsor/funder).
- Evaluation of data completeness regarding race and ethnicity reporting.
Main Results:
- A significant portion of AOM trials underreported race (43.7%) and ethnicity (25%).
- The majority of participants in analyzed trials were identified as white (69.9%), indicating disparities in representation.
- Domestic trials and privately funded trials showed higher rates of demographic reporting compared to international and publicly funded trials, respectively.
Conclusions:
- Pediatric AOM clinical research urgently requires improved participant diversity and more comprehensive demographic reporting.
- Despite guidelines, significant gaps in inclusivity persist, necessitating focused efforts.
- Prioritizing diverse populations in future AOM trials is crucial for ensuring equitable and universally applicable healthcare solutions.
Objective:
This study aims to assess the diversity and equity of pediatric acute otitis media (AOM) trials using ClinicalTrials.gov, focusing on participant demographics and representation to identify gaps in inclusivity and inform strategies for promoting diversity in future pediatric AOM studies.
Study Design:
Retrospective analysis.
Setting:
ClinicalTrials.gov.
Methods:
A retrospective analysis was performed on completed clinical trials enrolling pediatric patients with AOM, registered to ClinicalTrials.gov. Only trials that reported results were included. There were 48 trials, excluding duplicates, that matched these criteria. These trials were analyzed for data including study demographics (age, sex, race, ethnicity) and trial characteristics (location, sponsor/funder).
Results:
The analysis revealed that of the 48 trials, a significant portion underreported race and ethnicity, with 43.7% of trials reporting race and 25% reporting ethnicity. A majority of the participants identified as white (69.9%), showcasing notable disparities in representation. Domestic trials were more likely to report on race (50%) and ethnicity (30%) compared to international trials (22.3% and 0%, respectively). Privately funded trials reported at higher rates (53.3%) compared to publicly funded ones (38.9%), while the reporting of ethnicity was comparably low between both (20% and 33.3%, respectively).
Conclusion:
The study highlights the urgent need for more inclusive representation in pediatric clinical research, particularly in AOM trials. Despite guidelines aimed at improving demographic reporting, significant gaps remain. Future research efforts must prioritize the inclusion of diverse populations to ensure clinical trials are generalizable and equitable, thereby advancing toward developing more effective and universally applicable health care solutions for pediatric AOM.
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