Consultation outcome

MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

• From: Medicines and Healthcare products Regulatory Agency
• Published: 30 October 2020
• Last updated: 16 December 2021 — See all updates

This consultation has concluded

Detail of outcome

In October 2020, the MHRA launched a 6-week consultation with stakeholders on the MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions.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

Feedback received

Public feedback and detail of outcome

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Detail of feedback received

For a summary of public feedback, please see the document above.

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Original consultation

Summary

We want your comments on the clarity and wording of our new guidance

This consultation ran from
30 October 2020 to 11:59pm on 11 December 2020

Consultation description

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.

How to respond

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

Documents

Consultation document: MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

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Appendix 1: Description of MHRA divisions and centres

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Appendix 2: Algorithm to determine whether it's a clinical trial of a medicinal product

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Appendix 3: Risk-adapted approaches to the management of clinical trials of investigational medicinal product

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Response form

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Published 30 October 2020
Last updated 16 December 2021 + show all updates

1. 16 December 2021

   Final outcome of consultation published, including two guidance documents

2. 30 October 2020

   First published.