As part of a 2024 VEITHsymposium (New York City; Nov. 19–23) debate, Robert E Lee, MD, a medical officer recently retired from the Food and Drug Administration (FDA), presented an argument in favor of when the use of randomized controlled trials (RCTs) for the regulation and approval of novel vascular access devices becomes important.
“Randomization,” he stated, “helps assure that participants in both treatment groups are similar in the distribution of prognostic factors. This minimizes bias in statistical comparisons of patient outcomes when looking at both effectiveness and safety.”
“RCTs yield the highest level of evidence to establish causal associations in clinical research,” he said, so that there is no need for statistical sleight of hand with propensity scoring or other complex methodology to understand if a new therapy is more effective.
