The FDA intends to issue guidance on using real-world evidence (RWE) to aid in decisions about product effectiveness. Currently, there are several ongoing projects aiming to use RWE to replicate RCT results in order to identify circumstances and methods that provide valid evidence of drug effects. Inconsistent results between RCT’s and RWE may not be entirely attributable to faulty methods but rather to the difficulties inherent in emulating RCTs, bias, differences in patient populations and healthcare settings, differences in data analysis and effect measures and/or the efficacy–effectiveness gap. Read the full study here.
(Source: Sheffield KM, et al., Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions. Journal of Comparative Effectiveness Research. 11 Sep 2020)