MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

We have drafted new guidance providing points to consider when planning a randomised clinical trial using real world data, with the intention of submitting this trial to gain a regulatory approval - such as extending the use of a medication into a new indication or a broader patient population.

This guidance has been drafted with the input of the Commission on Human Medicines Real-World Data ad hoc group. It is intended to be the first in a series of guidance documents addressing issues around using real-world evidence in support of a regulatory submission.

The document considers aspects related to clinical trial authorisation, clinical trial design (including choice of endpoints and safety data requirements), and requirements in terms of database quality and inspection.

This 6-week consultation aims to get feedback from relevant stakeholders regarding the clarity and wording of this first piece of guidance, including any perceived contradictions or omissions.

1. Download the response form below
2. Complete the form and email it to rwe@mhra.gov.uk
3. Alternatively, send your comments directly by email to rwe@mhra.gov.uk