Randomized clinical trials (RCTs) are the best type of studies to investigate the causality between therapeutic interventions and outcomes. For this reason, RCTs are positioned at the top of the hierarchy of evidence. One of the potential caveats of these studies relies on the fact that they are rarely designed and powered to evaluate safety outcomes,1 which may hamper the ability to fully characterize drug-related harms. These limitations are even more evident when specific safety events are investigated.1
Caldeira D. Novel Antithrombotic Drugs and Intraocular Bleeding: The Importance of Observational Data and Future Perspectives. JAMA Ophthalmol. 2018;136(2):130–131. doi:10.1001/jamaophthalmol.2017.4179
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