What do participants need to do: Complete a consultation
How long will it take? Approximately 30 minutes, but this will depend on the views you wish to express.
Will participants get paid? No
Is this for research, policy or services? Policy
Who can take part? Individual cancer patients, their families or other caregivers, cancer patient groups.
Location: Online
Deadline: 31 March 2025
The MHRA would like to invite UK cancer patients and patient groups to comment on its draft guidance for developers of individualised mRNA cancer immunotherapies (colloquially referred to as ‘personalised cancer vaccines’).
These are a new type of cancer treatment that use mRNA technology. Unlike conventional cancer therapies, each patient receives a slightly different version of the mRNA therapy which has been matched to their unique tumour fingerprint. In this way the therapy teaches the patient’s immune system to target and destroy tumour cells.
With this guidance, the MHRA aims to facilitate patient access to these novel individualised cancer therapies by outlining a clear and streamlined regulatory pathway to approval. The guidance covers product design and manufacture, evidence needed to show safety and effectiveness, post-approval safety monitoring and patient information.
As someone affected by cancer, we would greatly value your help to finalise the guidance, particularly Section 8 which covers information for patients, healthcare professionals, and the public.
We know that at the time of a cancer diagnosis, patients may receive lots of information in a short space of time and be asked to make decisions on treatment options. We are particularly interested to know what type of information you think should be provided to support the decision to receive an individualised mRNA cancer immunotherapy. We would also welcome any general comments you may have on any of the other sections.
The draft guidance and consultation questions can be found here. The page includes a downloadable copy of the draft guidance and a link to the survey.
There is no payment for completing the survey. We estimate it could take 30 minutes to complete but this will depend on the views you wish to express. The survey closes on Monday, 31 March, 2025.
