We are seeking feedback on our new draft guideline on the use of external control arms based on real-world data to support regulatory decisions. While the guideline is specifically aimed at sponsors planning to use real-world data external control arms, many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials. This feedback will help us to improve the clarity and wording of this guidance, including any perceived contradictions or omissions.
Please download the draft guidance and consultation questions for reference before responding to this consultation here.
You can also leave specific line by line comments on the draft guidance. To leave such feedback, please download the MHRA spreadsheet here and refer to the draft guidance while completing it.
You have several rights which are outlined in the MHRA privacy notice. For greater detail on when they apply, please refer to the Information Commissioner’s website if you wish to exercise any of your rights, or have any questions or concerns, please contact our Data Protection Officer at dataprotection@mhra.gov.uk.
When the consultation period ends, the MHRA will amend and publish the guidance document and an anonymised summary of the public feedback.
The consultation will close at 11:59pm on Monday, 30 June 2025.