Understanding when real world data can be used to replicate a clinical trial: A cross-sectional study of medications approved in 2011.

Michael FralickEmily BartschJonathan J DarrowAaron S Kesselheim

Published in: Pharmacoepidemiology and drug safety (2020)

Among drugs FDA-approved in 2011, two (7%) had a pre-approval trial that could be replicated using insurance claims databases. In such qualifying trials, replication using claims databases could be useful in assessing whether they provide concordant results.

Keyphrases

drug administration
health insurance
clinical trial
big data
phase ii
phase iii
study protocol
affordable care act
open label
artificial intelligence
electronic health record
physical activity
machine learning
double blind
risk factors
randomized controlled trial
drug induced