RWD in Randomized Trials Must Apply Conventional Trial Standards, UK Says
Randomized clinical trials (RCT) in the UK can use real-world data (RWD) as long as they apply the same data standards used in conventional trials, according to a draft guidance the Medicines and Healthcare products Regulatory Agency (MHRA) published in late October.
Sponsors should describe the tools and methods to be used for the handling of RWD in their trial application to the MHRA, the guidance says.
The guidance says the protocol standards for a trial using RWD should be the same as used in a conventional RCT.
While the guidance says RWD is most likely to be used in trials involving approved products, the agency does not rule out the use of RWD in RCTs of new products.
The draft of RCT requirements is the first of a set of planned guidances on using RWD in different trial designs. MHRA has not specified the focus or release date for future RWD guidances.
Comments on the guidance are due by Dec. 11.
Read the draft guidance here: https://bit.ly/2U41T1b.