|Coronavirus: How affected covid19 in UK|
and welcome to this webinaron the UK government support for research related to COVID-19. My nameis Sarah Cooper,
I’m a Business Development Manager, I work for theNational Institute of Health Research Clinical Research Network and my job isto support companies who want to run clinical trials in the UK.
Today I’mgoing to talk to you a little bit about the UK-wide coordinated response to COVID-19 for research,
how we created a UK-wide system for prioritizing studiesand needs to be conducted around COVID-19,
how you can get your study badged as aUrgent Public Health for COVID-19 and then give you a few examples of studiesthat we are delivering in this area,
give you a flavor of the types of studieswe’re delivering,
and also the timelines for setup – I’m going to conclude by justtelling you a little bit about our restart framework as we start to reopenour portfolio.
The slides are available in the link shown on this first slide.
he has overallresponsibility for the NIHR. During the COVID-19 Urgent Public Healthresearch has been prioritized to gather necessary clinical and epidemiologicalevidence that will inform national policy and it allows us to test newdiagnostics,
treatments and vaccines that are crucial in the management of COVID-19 in the UK.
the UK, combining this with our knowledge of where COVID-19 cases areallows us to appropriately maximize the use of our resources across the UK.
UrgentPublic Health Research that’s badged by the CMO is expedited through ourstudy setup and delivery activity.
How to apply for this – you can look on the NIHR website,
and it’s worth being mindful that only studies that are badgedas Urgent Public Health research will receive expedited study set up anddelivery support.
So what’s the process? Firstly you need to provideus as much information as you can about the study: it should include the IRASnumber if you have it. It’s an online application form and the link can beseen in the slide.
Your study will then be reviewed by theurgent public health group and the CMO.
If your study is deemed to be badged youthen get access to expedited services such as identification of sites andcosting validation. We do this in a coordinated manner across the healthresearch and social care systems and this is managed by the NIHR.
This slide just shows you the webpagewhere you can go to apply to be badged and tells you the process.
You candownload the application form so you can see what the questions are ahead of youdoing your application.
Okay, so I just wanted to go on and speak to a littlebit about some of the – I guess – outputs from some of the other regulatoryagencies that we’re working in collaboration with, and so the MHRAthey’re obviously prioritizing and providing assistance to clinical trialsaround COVID-19, they’re providing rapid scientific revise and they’re ensuringthat they can turn around studies applications in two to eight days,
and atthe moment they’re average approval time is 7.8 days – and that’sbased on 47 studies. Likewise the HRA have got some data here on their time forapproval
– so for CTIMPs, they’ve got 20 studies that they’ve so farapproved and that’s within a median time frame of 8.5 days, but othertypes of studies,
and we have 81 in that category,
the medium time frame is 6 days -so you can see both these agencies are able to have a rapid turnaround ofapprovals in this situation. NICE are also providing free fast-trackscientific advice for those wanting to develop novel diagnostics ortherapeutics for COVID-19 and implement information on how to accessthis service is available through their website.
So what have we done so far?
Well 46studies have been nationally prioritized and you can find out about which those studies are on our website.
Of those 46 studies 26 of those haverecruited and they’ve recruited over a 100,000 participants which is astaggering number within the time frame,
and that number rises rapidly on adaily basis.
They aim to review yourproposals within four weeks,
and information there on how to access thatas well.
So let’s go through some examples,
tryingto pick out a range of examples and demonstrate the the different types ofstudies that we’ve been supporting during this crisis. So the first one is acommercial contract study from Novartis – it’s a phase three trial, its globaltarget is 366,
UK target of 40 and this is being done acrossfive sites.
It took 33 days to set up and the great thing about this study is wewere able to get a global 1st.
This one is quite different – it’s amulticenter seamless phase to adaptive randomization platform study and thiswas announced by the government on the 28 of April and is a collaborationbetween different partners including the Department of Health and Social Care,
UKRI, IQVIA and it will be delivered through the NIHR researchinfrastructure.
As we come to the end – potentially – of thetreatment phase of research we are looking forward to supporting vaccinetrials in the UK, and this just gives an example of a vaccine study that we’realready supporting.
So this is a phase 1/ phase 2 vaccine trial in healthy adultvolunteers,
it’s funded through that rapid response call that I previouslymentioned,
originally a sample size was 510 but they’ve greatly exceeded thatand we’re currently on 1077 participants across 5 sites.
RECOVERY – this is another adaptive trialdesign.
It’s in an acute setting and the thing about this study is the volume ofparticipants that they’re recruiting – so they’re aiming to recruit 12,000, itactually achieved 10,000 patients in 8 weeks and 9 minutes which is anincredible feat, and that’s across 176 sites,
and this study is very close toachieving its target.
My final example is actually anobservational study. This is a study that was actually set up a long time ago andhas been activated for other outbreaks such as Ebola and MERS.
Its funded by theWellcome Trust and it was very early to get it set up because it had thosepre-approvals.
The first patient was actually recruited within January 2020,so one of the first diagnosed patients within the UK took part in this study. Hasa 150sites now and it’s designed to maximize data collection in a way that can be shared in a rapid format,
and actually the outputs of thisstudy do inform the Sage Group.
So finally I just like to mention ourrestart. So when COVID-19 hit we did pause our portfolio for all studiesother than the Urgent Public Health studies which were prioritized.
We arenow in the process of reactivating our portfolio and aim to have a full andactive portfolio once more.
In order to support us in this we havecreated a restart framework and this allows you to think about key activitiesyou’ll need to take place before you can activate your study – so thinkingabout study viability,
safety, capacity and site readiness,
and of courseprioritization.
The Urgent Public Health prioritized, badged studies will still takepriority. If you want more information it can be found in the full frameworkdocument and I’ve provided a link for that in the slides.
If you have any further questions aboutrunning COVID-19 research in the UK please contact your account managerdirectly, or come through the details provided on this slide.