UK’s First Real-World Evidence Guideline Targets Randomized Trials

The UK medicines regulator is inviting stakeholder feedback on a draft guideline on the general factors that drug companies should consider when planning a prospective randomized trial using real-world data (RWD) sources.

The guideline on randomized control trials (RCTs) is the first in a series of guidance documents that the Medicines and Healthcare products Regulatory Agency intends to publish to address issues around using real-world evidence (RWE) in support of a regulatory submission