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Home » Evidence of Validity Needed to Use RWD in Randomized Trials, UK Says
Evidence of Validity Needed to Use RWD in Randomized Trials, UK Says
Sponsors of randomized clinical trials (RCT) using real-world data (RWD) to support regulatory decisions in the UK should show they have applied the same data validity and integrity standards used for conventional trial sources, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October.