Premature termination of interventional ophthalmology clinical trials from international registries

Abstract

Globally, a multitude of interventional clinical trials are terminated prior to completion. We sought to identify and analyze trends related to the reporting of these trial results. We conducted a retrospective, cross-sectional study of interventional clinical trials in the 16 primary registries of the World Health Organization Network as well as ClinicalTrials.gov dating back to 2003. A total of 250 studies were identified, of which 135 (54%) were sponsored by academic institutions. A staggering 244 trials (98%) did not lead to publication of results. In sum, a total of 22,420 patients participated in clinical research from which the results were not widely disseminated. 75% of trials were discontinued for unspecified or unclear reasons; 10% were terminated due to inadequate patient accrual. New policies and initiatives have helped usher in an era of improved methods for trial reporting and, in turn, provided the opportunity to perform more interventional trials. However, further action is needed to ensure that findings of all trials are shared with the ophthalmic community in order to build a more comprehensive body of knowledge and decrease potential redundancy.