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Title:

Discontinuation and non-publication of cataract surgery-related interventional clinical trials


Poster Details

First Author: N. Khanna USA

Co Author(s):    Y. Vaishnav   H. Moreira   M. Gallagher   T. Yilmaz           

Abstract Details

Purpose:

Although there are a multitude of cataract-based clinical trials that take place globally, a paucity of literature regarding the discontinuation and non-publication of such trials exists. We sought to evaluate the prevalence of non-publication in completed as well as discontinued interventional clinical trials as differentiated by both industry and academia.

Setting:

Not Applicable

Methods:

A retrospective, cross-sectional study of cataract surgery-based interventional clinical trials in ClinicalTrials.gov between 1992-2020 was conducted. ?2 and Fisherï¾’s exact tests were used to determine any potential associations between trial characteristics and trial completion.

Results:

A total of 458 trials were evaluated in this study, 33% U.S.-based, with a 14-fold increase in the number of trials in the past fifteen years. Of the included trials, 88% were not published and 89% were completed; however, only 34% published results of their study on ClinicalTrials.gov. Devices and procedures accounted for 66% of the intervention types investigated. A total of 50.005 participants were enrolled in unpublished, completed trials; whereas 5.583 participants were enrolled in unpublished, discontinued trials. We found no statistically significant differences in the odds of nonpublication or discontinuation between industry and academia-sponsored trials (p=0.43, 0.10, respectively).

Conclusions:

New policies and initiatives have helped usher in an era of improved methods for trial reporting; however, further action is needed to ensure that findings of all trials are shared in order to build a more comprehensive body of knowledge and decrease redundancy. Publication of inconclusive or negative results ensures that all research activities, regardless of outcome, contribute to a more robust, global medical literature.

Financial Disclosure:

None




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