 Engaging with sponsors on new research transparency proposals
As part of our work with the Medicines and Healthcare products Regulatory Agency (MHRA) on updates to clinical trial legislation, we need sponsors to tell us how we might best implement the transparency commitments made in the government’s consultation response.
These commitments cover new legal requirements to register a trial, to publish a summary of results within 12 months of the end of the trial unless a deferral has been agreed, and to share trial findings with participants in a suitable format.
We’re asking about three specific proposals:
- Standard 30-month time period to fully comply with research transparency requirements for early phase trials
- Extension to standard 30-month time period where a patent application is ongoing
- Fixed time point for registration
If you sponsor clinical trials and have not yet shared your views, there’s still time. We have extended the closing date for responses to Tuesday 27 February. For a copy of the detailed proposals and feedback form, you can contact us at Engagement.Team@hra.nhs.uk.
You can read more about other work we’re doing to support research transparency and clinical trial registration further down this newsletter.
 Make it Public Week returns for 2024
We’re delighted to announce #MakeitPublic Week is back for its second year, from 18–22 March.
Make it Public Week is a campaign dedicated to research transparency, founded on the Make it Public strategy and our vision that trusted information from health and social care research studies is publicly available for the benefit of all.
This year, we’re focusing on raising research registration rates. We know that two thirds of the UK public would feel more confident in the findings of health and social care research if the project was added to a public register before it started.
We’ve been looking at how we can support higher registration rates and increase visibility of studies taking place in the UK. From this year onwards we’ll be publishing the data that we routinely collect about clinical trials we have approved, and whether they have been registered on a publicly accessible database. We’ve also reviewed the current data we hold, and have contacted research teams where we do not have a record that their trial has been registered.
And this Make it Public Week, we want to bring the research community together for an online workshop to explore themes in research registration and address any barriers to registering studies.
The workshop takes place on Thursday 21 March and you can sign up today.
Update on our inclusion and diversity work for clinical trials
As many of you will know, we’ve been working with the MHRA to produce an Inclusion and Diversity Plan to support the new UK clinical trials regulations. This consists of a set of questions and guidance for research teams to help them identify who could benefit from their study, and how they can design it to ensure that people underserved by research are not overlooked.
The next step for this work is to share the draft questions and supporting guidance with the wider research community and the public for comment. We now expect to consult on this informally in late spring and will keep you updated.
In the meantime, you can hear from our Policy Manager Jane Morrin O’Rourke along with one of our public contributors, who reflect on working together to develop the questions and guidance and the difference this has made. Read their blog on our website here.
For more information about our diversity work and good practice resources and tools to support researchers, visit our dedicated webpage.
Supporting researchers to involve the public in trial design and delivery
Work continues to make sure researchers have the guidance they need to better support public involvement in the design and conduct of clinical trials.
The new public involvement guidance working group has been busy on a number of fronts since our call for information survey last Autumn. Respondents identified a gap when it came to Phase I healthy volunteer trials, so a writing sub-group is drafting specific guidance and expectations for these studies. This will include what information will be expected in applications for ethics review.
The working group will also have their second full meeting on 29 February, where they’ll review resources that respondents told us they currently use across a range of different trial types. The group will then produce a summary of recommended existing guidance for us to make available, along with a set of expectations for patient and public involvement in clinical trials, in line with the Shared Commitment to Public Involvement and the UK Standards for Public Involvement.
And the work doesn’t stop there. The group will be considering other therapeutic areas identified as having no widely available guidance and where some may be needed, for example clinical trials for rare diseases.
We look forward to keeping you updated on our progress in future issues. In the meantime, if you have any queries please contact Jim Elliott, Public Involvement Specialist at public.involvement@hra.nhs.uk.
In other news...
Declaration of Helsinki revisions: our response
We’ve responded to a consultation, led by the World Medical Association, on revisions to the Declaration of Helsinki. The Declaration, a statement of ethical principles for medical research involving humans, is regarded as the most important document in the history of research ethics. It informs our work every day, and is referred to in both the UK’s Clinical Trials legislation and the UK Policy Framework for Health and Social Care Research.
The aim of the revisions is to help ensure the Declaration continues to address evolving global ethical challenges. We co-ordinated a response working with our devolved partners, Research Ethics Committee (REC) members and public contributors, which you can read now on our website.
Removing barriers to research: responding to the Tickell review
Last week we welcomed the government’s response to Professor Adam Tickell’s Independent Review of Research Bureaucracy.
The government’s response includes plans to improve efficiency and productivity in research, and highlights work we have already carried out to reduce bureaucracy.
This includes improvements we’ve made to our approvals through our combined review service with the MHRA.
Read the full HRA response on our website.
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