The UK medicines regulator has finalized much-awaited guidance explaining how drug sponsors can conduct randomized controlled trials (RCT) primarily using real-world data (RWD) sources to support a regulatory decision relating to a medicinal product.
UK Explains How To Plan For Randomized Trials Using Mainly RWD Sources
Guideline Does Not Cover Clinical Trials Using RWD As A Control Arm
The UK Medicines and Healthcare products Regulatory Agency has finalized the first part of a series of new guidance documents addressing issues around using real-world data in support of regulatory submissions.
