Open AccessPublication Rates of Registered Clinical Trials in Diabetic Macular Edema
Author(s) -
Patrick J. Hughes,
Richard N. Polo,
Howard F Fine,
Jonathan L. Prenner
Publication year - 2021
Publication title -
the open ophtalmology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.67
H-Index - 19
ISSN - 1874-3641
DOI - 10.2174/1874364102115010005
Subject(s) - medicine , clinical trial , diabetic macular edema , ophthalmology , diabetes mellitus , diabetic retinopathy , endocrinology
To determine the publication rate of registered clinical trials evaluating therapeutic approaches for diabetic macular edema (DME). Methods: Using the search terms “Diabetic Macular Edema,” the National Institute of Health’s ClinicalTrials.gov online registry was searched to identify all clinical trials concerning DME. Non-interventional trials, terminated trials, trials not concerning DME, and those not completed between 2005 and 2015 were excluded. Publication status of each trial was determined using searches of the study title, keywords, author(s), and NCT number on PubMed.gov and Google Scholar. Results: A total of two hundred and forty-seven studies were identified in the primary analysis. Of the 97 trials meeting inclusion criteria, 60 (61.9%) were published. Late-phase trials were published at higher rate (74.5% [35/47]) than early phase trials (50% [25/50]) ( p = 0.01). Trial location, date of completion, and industry involvement did not significantly affect the publication rate. Conclusion: Of the registered trials listed in the ClinicalTrials.gov registry investigating DME, 61.9% were published.