 Creating public involvement guidance for clinical trials
We want to support researchers to involve people with lived experience more often and in meaningful ways.
To help us provide the guidance that researchers need, we ran a survey to better understand what guidance is currently being used to involve patients and the public in the planning and delivery of clinical trials.
We asked respondents to share examples of the resources they use, their views on them and if there are areas of clinical trials where new guidance would help. The survey launched on 23 August, closing on 6 October.
We were delighted to hear from people working with a variety of organisations. If you took part in this survey, thank you!
 We received:
- 92 responses
- 85 URLs (web links to resources) of which about 60 were unique
- 16 documents
- Public involvement strategies, a range of guidance documents, standards, policies, resource lists, published papers, information leaflets and toolkits
We heard from:
- A mix of commercial sponsors, contract research organisations (CROs), NHS organisations, universities, clinical trials units, charities and patient advocates
Overall, what did respondents tell us?
- A wide range of resources are being used to help involve the public in clinical trials, of which six were cited by multiple respondents
- Fifty nine of the 92 respondents identified one or more aspects of clinical trials where they would benefit from new resources or were unaware if any existed
What’s next?
The next stage of this work is to review all the information that’s been shared with us in more detail, produce a summary of recommended existing guidance and plan for any new resources that are needed.
A new working group will be helping us to do this. This will be made up of people involved in the design and conduct of clinical trials, who either work for organisations that plan and deliver research or are public contributors with previous experience of involvement.
If you would be interested in joining this working group, it’s not too late to let us know. Express your interest today by contacting Jim Elliott, Public Involvement Specialist at public.involvement@hra.nhs.uk
Increasing the diversity of participants in research
Work has continued apace with the MHRA on joint guidance to help researchers recruit a diverse group of people to clinical trials.
During August and September, we hosted a series of workshops where we worked closely with a small group of researchers, funders, sponsors, Research Ethics Committee members and the public to develop initial drafts of questions that will form the basis of a new inclusion and diversity plan and supporting guidance on how to complete the plan. We’re now busy refining the drafts and plan to share them as part of a wider consultation towards the end of the year/early 2024. We’ll share further updates on this with details of how you can participate soon.
Membership and make up of Research Ethics Committees (RECs)
As part of the update of UK clinical trials regulations, we have the opportunity to change the way we make up our RECs and categorise members in the future.
In an online survey this summer, we invited views on our new proposals about how we might change the way in which we describe members of RECs as expert or lay, and about what RECs might look like in terms of the membership and expertise.
Many thanks to those of you who shared your thoughts with us. We were delighted to receive 227 responses from REC members across the UK and some members of the public who don’t currently work with a committee. We were pleased to receive support about the need to be clearer in terms of how we describe members of RECs. We also received lots of helpful suggestions and considerations in the free text responses to the survey.
We’re now in the process of using the findings and feedback from the survey to develop a more detailed proposal, working with our colleagues across the UK and our REC members and Chairs, Vice Chairs and Alternate Vice Chairs. Moving ahead with any changes will be in line with implementation of the revised regulations. In the meantime, please see the supporting information on our website explaining why we are looking to make some changes. If you missed the survey but would like to share your thoughts, please contact Charlotte Allen, Quality and Performance Manager at charlotte.allen@hra.nhs.uk
Clinical trials in the news
You may have seen that the MHRA has announced a new streamlined notification scheme that will see them process the lowest-risk, late-stage clinical trials within 14 days.
The new scheme is about making regulation more flexible and proportionate to risk based on the clinical trials consultation, and reducing review timelines.
You can read the announcement in full on gov.uk. This sets out more details about the scheme, including eligibility and how it will work. There is also a quote from Dr Janet Messer our Director of Approvals, who refers to the UK’s fast-track ethics review service and how we’ll be exploring how the services could work side by side in the future.
Patient centricity and the UK’s pivotal role in human clinical research
Janet has also written a blog about work we're collectively doing in the UK to make it easy to do world-leading research here that people can trust. Read it on our website
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