Making clinical trials public
Thank you to everyone who joined us for Make it Public week last week. On Thursday over 100 people were part of our webinar on clinical trial registration. We heard from people who have been part of research about the difference that registration makes, about best practice across the UK and beyond, and about some of the barriers to registration.
We’re getting ready to share the highlights of the event with everyone who couldn’t attend. Keep an eye on the Make it Public campaign page on our website for more information.
And in case you missed it, earlier last week we published our latest audit of clinical trial transparency. We’ve been sharing the proportion of trials registered every year since 2015. This year, for the first time, we were able to audit a full 12 months of data and, after following up with studies for which we didn’t have a record of registration, share the data on a trial-by-trial basis.
We found that 92% of trials were registered, which is another year-on-year increase moving us closer to our goal of 100%.
Talking trials
This week our Director of Policy and Partnerships Becky Purvis spoke at the Westminster Health Forum as part of an event on next steps for clinical research in the UK.
Becky spoke about how trusted trials, with regulation which is predictable, proportionate and easy to navigate, can help increase participation, making it easier to recruit diverse cohorts and improve retention. She also reflected on the commitments from the government in response to Lord O’Shaughnessy’s review of clinical trials, and the HRA’s work to support his recommendations.
You can read more about our response to the O’Shaughnessy review, which shapes our current work on trials, on our website.
Later this week our Deputy Director of Policy and Partnerships, Naho Yamazaki, and our Policy Manager, Jane Morrin O’Rourke, are meeting members of the Association of British Pharmaceutical Industry (ABPI) to talk about our upcoming inclusion and diversity guidance for clinical trials.
Shared Commitment to Public Involvement
Last week you may have noticed that we celebrated the second anniversary of the Shared Commitment to Public Involvement. The commitment, from 22 organisations including research sponsors and funders, demonstrates that public involvement is important, expected and possible in all types of health and social care research.
We’re continuing our work to make sure that all researchers have the guidance they need to better support public involvement in the design and conduct of clinical trials. Our new guidance for Phase I healthy volunteer trials, including the information expected in applications for ethics review, is coming soon. Look out for more on our website.
For more information, contact public.involvement@hra.nhs.uk
People-centred clinical research
We’ve also been out and about this month talking about the hallmarks of people-centred clinical research.
The hallmarks were developed by a as part of the Recovery, Resilience and Growth (RRG) programme.
For clinical research to truly benefit health and care, and make a difference in the real world for everyone, we must make sure people are at its heart. Research should be people-centred as well as ethical, legally compliant and conducted with scientific integrity.
The hallmarks are a call to action for research teams to understand what matters to the people taking part in research. You can read more about them on our website, and download them to use yourself from our shared drive.
In other news...
National Contract Value Review (NCVR)
Co-ordinating and standardising the practice of research regulation is a top priority for the HRA. The more the processes are joined up, the easier and quicker it is to do high-quality research that people can trust.
And one thing that we know makes a big difference to researchers is speeding up the time it takes to set studies up.
Earlier this month it was announced that 100% of NHS trusts are now implementing a standardised way to price commercial research as set out by the National Contract Value Review (NCVR) – speeding up the set- up of commercial studies in the NHS and ultimately leading to UK patients accessing new treatments quicker.
You can read more about how the HRA supports NCVR and the difference it’s making on our website.
DigiTrials
NHS England now has an updated tool to help find and locate participants for clinical trials across England.
NHS DigiTrials Feasibility Self-Service enables researchers to independently search 63 million participants across NHS national datasets, to count and locate eligible participants for trials without ever revealing identities. Researchers have the flexibility to search using different criteria such as demographics, diagnoses, procedures and medications to identify specific patient cohorts. They can run multiple searches until they reach their target. The results are presented in aggregate tables or as a heat map providing insights into the hotspots across England.
You can read more on the NHS England website.
Podcasts
And in case you missed it, our colleagues in combined review, the Medicines and Healthcare products Regulatory Agency (MHRA) are producing a series of podcasts with New Scientist.
The episodes shine a light on the UK’s world-leading landscape for life sciences research and development, going behind the scenes to look at the work making this a great place to do clinical trials. Episode one featured Lord James O’Shaughnessy, and you can listen to this and subsequent episodes on the New Scientist website.
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