Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says

Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.

SAN DIEGO – The US Food and Drug Administration expects that its study to reproduce the results of randomized controlled trials using real-world evidence will fail to replicate in some instances – a result that could drive a better understanding of how to use claims and other real-world data.

Asked during a 25 June session of the DIA annual meeting, Center for Drug Evaluation and Research's David Martin acknowledged...