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Publication Rates of Registered Corneal Trials on ClinicalTrials.gov
Eli K Cehelyk1, Marcos A Crespo2, Zeba A Syed2
1Thomas Jefferson University, Philadelphia, PA; and.
Purpose:
This study aimed to characterize cornea-centered clinical trials, completed before 2020, registered on ClinicalTrials.gov and identify discrepancies in publication.
Methods:
ClinicalTrials.gov, a database from the National Institutes of Health, was queried to identify registered cornea-related clinical trials. Trials were included if they were interventional and completed before January 1, 2020. ClinicalTrials.gov, PubMed.gov, and Google Scholar were then searched to evaluate publications from the trial. Data collected for each trial included sponsor, intervention type, phase, dry eye focus, and location of the principal investigator.
Results:
A total of 520 trials were included in the final analysis. Of all studies, 270 (51.9%) were found to have published results. Industry-sponsored studies were associated with drug intervention trials, dry eye focus, and the principal investigator's location within the United States ( P < 0.05 for all). Nonindustry sponsors were associated with device and procedure intervention trials ( P < 0.05 for both). Overall, trials that were categorized as procedure interventions were published at a significantly higher rate than other interventional categories (64.2% vs. 50.1%; P = 0.03). Subgroup analysis revealed that among nonindustry studies, late-phase trials and procedural-based trials were published at a significantly higher rate compared with other studies (67.2% vs. 51.6%; P = 0.04 and 67.8% vs. 51.6%; P = 0.03).
Conclusions:
Only 51.9% of registered interventional cornea-based clinical trials result in publications in the peer-reviewed literature, highlighting potential publishing discrepancies.
Insights
Publication rates for cornea clinical trials are low, with only 51.9% of registered studies published. This highlights potential publication bias in ophthalmology research, particularly for non-industry sponsored trials.
Area of Science:
- Ophthalmology
- Clinical Research
- Publication Ethics
Background:
- Cornea-centered clinical trials are crucial for advancing ophthalmic treatments.
- Understanding publication patterns is essential for assessing research impact and identifying potential biases.
Purpose of the Study:
- To characterize cornea-centered clinical trials registered on ClinicalTrials.gov before 2020.
- To identify publication discrepancies between registered trials and peer-reviewed literature.
Main Methods:
- A systematic search of ClinicalTrials.gov identified interventional cornea trials completed before January 1, 2020.
- Publication status was assessed by searching ClinicalTrials.gov, PubMed.gov, and Google Scholar.
- Data on sponsor, intervention type, phase, dry eye focus, and investigator location were collected.
Main Results:
- Of 520 trials, 51.9% had published results.
- Industry sponsors predominantly funded drug trials for dry eye in the US.
- Non-industry sponsors focused on device and procedure trials, which had higher publication rates (64.2%).
- Non-industry, late-phase, and procedural trials showed significantly higher publication rates.
Conclusions:
- A significant publication gap exists for cornea-based clinical trials, with over 48% remaining unpublished.
- Publication rates vary by sponsor and intervention type, suggesting potential biases in the dissemination of research findings.
- Further investigation into factors influencing publication is warranted to ensure comprehensive scientific knowledge in ophthalmology.
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