Although randomized clinical trials are considered to be the gold standard for generating clinical evidence, the use of real-world evidence to evaluate the efficacy and safety of medical interventions is gaining interest.
In this latest article from JAMA, researchers question the feasible of replicating clinical-trial evidence using real-world data.
In 2017, a total of 429 prospective clinical trials were published in high-impact general medical journals. Of these, 220 met the study's inclusion criteria and were included in the analysis. 147 (66.8%) of these trials tested pharmaceutical interventions.
Of the 220 clinical trials, 204 (92.7%) were randomized and 16 (7.3%) were not. Of the RCTs, 113 (55.4%) were double-blind, 30 (14.7%) were single-blind, and 61 (29.9%) were open-label.
The study concluded that only 15% of the published clinical evidence could feasibly be replicated using currently available real-world data sources.