Guidance

MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

Points to consider when using real-world data in clinical studies

Documents

Details

In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions.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.

Please visit the consultation webpage for more information on the original consultation, including responses received.

Updates to this page

Published 16 December 2021

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