Abstract P2145: A Review Of Trends In Cardiovascular Medicine Clinical Trials; 2012-2021

Abstract

Introduction: We examine cardiovascular medicine clinical trials (CTs) from the United States over the past decade focusing on characteristics that are important for assessing the reliability of evidence derived from them. Methods: The Clinicaltrials.gov API interface was queried with a comprehensive search strategy to identify trials in the field of cardiovascular medicine from the US registered from 1/1/2012 till the 12/31/2021. We extracted data on the presence of data monitoring committees (DMC), masking status and allocation methods used in the CTs. Results: Our initial query identified 1299 CTs. After reviewing and excluding unrelated trials, 536 were found to be cardiovascular medicine CTs. Of these, 507 (95%) reported if they had a DMC or not, 261 (49%) reported having a DMC while 246 (46%) reported not having one. 471 (88%) CTs reported on their design allocation method, most common being randomized as reported by 312 (58%) of the trials, 43 (8%) were non-randomized and 116 (22%) reported that a design allocation was not applicable to them. 471 (88%) CTs reported on their masking status, most common being open label as seen in 247 (46%) of the trials followed by double masking seen in 71 (13%) of the trials. On performing a Cox and Stuart trend test, no trend was seen in the annual proportion of trials with randomization, a DMC or masking over the past decade [P > 0.05 for all three]. Conclusions: In these analyses of 536 CTs, we found that > 50% did not have a DMC or any masking and no favorable trend was seen in the annual proportion of same over the past decade. Additionally, majority of the trials reported randomization as the design allocation method.