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MHRA - MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

21st December 2021

In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions. Following the consultation and an analysis of the responses received, the MHRA has published two guidance documents:

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

This provides an introduction to the MHRA’s real-world data (RWD) guideline series, and points to consider when evaluating whether a RWD source is of sufficient quality for the intended use.

MHRA Guideline on Randomised Controlled Trials using Real-World Data to Support Regulatory Decisions

This provides points to consider when planning a prospective randomised trial using RWD sources with the intention of using the trial to support a regulatory decision. The guideline covers clinical trial authorisation (if applying for approval to run such a trial wholly or in part in the UK), and clinical trial design including choice of endpoints and safety data requirements.

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