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

 
• By Vibha Sharma

The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.

Real world data
Randomized trials using RWD are most likely to be considered for label changes • Source: Shutterstock

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...

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