Abstract
Registry based randomized controlled trials (RRCTs) allow for outcome ascertainment using routine health data (RHD). While this method offers a potential solution to the rising cost and complexity of traditional RCTs, a rigorous quantitative analysis between sources of RHD has yet to be systematically performed to compare results to traditional outcome ascertainment by clinical endpoint committee (CEC) adjudication. Among cardiovascular (CV) trials, we set out to compare the incidence of CV events and estimated randomized treatment effects ascertained from RHD versus traditional clinical evaluation and adjudication.
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