ASA Connect

RCT-DUPLICATE Project

https://www.rctduplicate.org/projects.html

First Findings

https://aetion.com/company/news/first-rct-duplicate-findings-published-in-circulation/

• Nine of the 10 RWE studies achieved at least two of three agreement metrics that researchers set at the outset.
•  For each of these nine studies, the difference in results between the RWE and RCT was not statistically significant.
•  Eight of the nine RWE findings achieved "estimate agreement," which means they fell within the 95% confidence interval of the RCT results. Six of the nine studies achieved "regulatory agreement," meaning that interpretation of the respective RWE and RCT results would lead to equivalent regulatory decisions.
• The tenth RWE trial emulation did not meet any of the three agreement metrics.

"The results indicate that in certain circumstances RWE studies can meaningfully supplement RCT evidence, or even replace some large-scale randomized safety trials."