Hello and welcome to this webinar on how
the National Institute of Health
Research, or the NIHR, can support the
delivery of clinical trials in the UK. My
name is Theo Christie and I'm one of the
business development managers for the
NIHR's Clinical Research Network. During
this webinar I will provide an overview
of the UK clinical research landscape,
and the support available to the life
sciences industry.  Whether you're from a
large or small pharma company, a biotech,
a medtech, a CRO, or an SME. Now to
start things off it's important to begin
with a quick introduction into one of
the UK's most unique selling points, and
that is, of course, the National Health
Service.
Now the NHS was launched over 70 years
ago to provide free healthcare at the
point of access for all residents in the
UK. This is a principle that still holds
true today providing care for a
population of over 63 million people.
This includes everything from antenatal
screening to end-of-life care, from
routine treatments for long term
conditions to emergency treatments. The
NHS is the largest publicly funded
health service in the world and treats
almost 1.5 million patients every 24
hours, and with such a large population
to provide around-the-clock care for, the
NHS is also one of the largest employers in
the world with a staff of around 1.7
million employees. Now it's also
important to talk a little bit about the
wider clinical research landscape within
which the NHS exists. This is a landscape
that receives strong political backing
and is evidenced through a number of
publications in the last decade. The
strategy for UK Life Sciences was
launched in 2011 and this set out a
vision that the UK would be a global hub
for the life sciences industry. In
subsequent publications in the following
years the NHS responded and focused on
ways in which to accelerate innovation
in the NHS and also established
commitments to ensure clinical research
was embedded as part of everyday
clinical care. In September 2017
professor Sir John Bell penned the 'life
sciences industrial strategy'. This
identified challenges and provided
recommendations on how government could
maintain and develop upon its
existing strength as a world-leading life
sciences ecosystem. Following on from this.
later in 2017, was the life sciences
sector deal. This was the government's
response to a more ambitious
industrial strategy and it put forward
commitments on how these recommendations
could be delivered. Key areas were to
raise the intensity of R&D in the UK
through further investment and also
through strengthening the environment
for clinical trials through investment
in the National Institute of Health
Research infrastructure. To add further
granularity to these proposals, the
second sector deal was published in
December 2018 this provided more clarity
on how these commitments would be
delivered and focused on a number of key
areas such as: increased funding and a
strong focus on genomics digital
advancements, artificial intelligence, in
diagnostics, and making clinical research
processes more streamlined, efficient, and
innovative. With particular focus on this
last part the National Institute for
Health Research has been involved in a
number of work streams to provide the
support to ensure these commitments are
delivered . We continue to work with NHS
England and other stakeholders to
simplify the costing and contracting
processes. We are supporting the improved
delivery of clinical trials through the
establishment of five dedicated centers
of excellence for late phase commercial
research, and working with our IQVIA to
develop a northern prime site. Other
areas include the promotion of the UK's
capability to deliver innovative trials
and the working on developing an
e-learning skills program around this
area. We're also supporting a programme to
incentivize patient referral models
through the use of participation,
participant identification centers (or
PICs). So I've already mentioned the NIHR
several times, but what actually is
it? So the National Institute of Health
Research was established in 2006 by the
Department of Health and it was
established to improve the health and
wealth of the nation through delivering
research.  It is globally unique. It has a
fully integrated research system
embedded within the NHS, supporting
clinical research within the
NHS, and the wider health and social care
system too. The NIHR is funded by
government and receives a generous 1
billion pounds per annum with half of
this going towards various funding
programmes to finance research and the other
half being spent on world-class
facilities to ensure the delivery of
research. Now this slide shows examples
of some of these funded infrastructure
covering the full spectrum of clinical
research, whether that's molecules or
technologies, from invention to adoption,
from bench to bedside, this includes
early phase proof-of-concept
translational research, and right through
to later phase clinical research. A key
part of the infrastructure is the
Clinical Research Network highlighted
here, and what I believe is coral. The
Clinical Research Network (or CRN) is a
national research network, it is fully
embedded within NHS England to deliver
both commercial contract research, and
academic research. Structurally we are
comprised of national coordinating
centers and 15 local clinical research
networks (or LCRNs) and these are
dotted around the country giving us a
hundred percent coverage of the country
shown here by the numbers within this
image. Through operating in this way each
LCRN has a detailed understanding of
their patient populations and
understanding of the care pathways and
all the research active healthcare
providers and their staff. It's also
familiar with the the new and
up-and-coming researchers, and the new
green shoots sites that are coming
through that are available to take part
in research. The way we work allows
flexible deployment of resources based
on where there is need region to
region, and also enables us to carry out
the services we provide to industry. We
work very closely with our colleagues
and the devolved nations of Wales
Scotland and Northern Ireland, and this
enables a number of our services to be
delivered UK-wide. As this next image
shows, we support research across 30
different specialty areas which includes
absolutely everything from cancer right
through to oral and dental. We have a
panel of 15 research engaged clinicians
for each of these specialty groups and
these are made up of representation from
each of the 15 regions.
What this gives us is a clinical
specialty group for each of these 30
areas that can provide support across
several services that we offer which I
shall go on to shortly. Now to give you
an idea about the the scale of the
research that the clinical research
network supports I just wanted to run
through a few figures from our last 
financial year's reportings. We supported
740 new commercial trials in 18/19 when
you combine that with academic research
as well this was almost 2200 new
research studies that came onto our
portfolio. When we look at participants
recruited we have upwards of eight
hundred and seventy thousand patients
recruited onto both academic and
commercial contract research, just within
commercial this is 46 thousand patients.
To give you an idea of all the companies
that we've worked with since our
initiation in 2006, we've signed over
eleven hundred and fifty new CDAs. We're
also measured by Department of Health on
how we perform for delivering studies
time to target, so across both portfolios
(non commercial and commercial) we had 82
percent of all studies hit their patient
target within their timeline. For
commercially speaking this was 69
percent, and this is very much, if you
need ten patients it has to be ten
patients, for us to to mark this as a
result. Across the country we had a
hundred percent of NHS trusts that were
research active. This is every single
trust in the country took part in some
type of research, either commercial or
non-commercial. When we just look at the
commercial side of things this was 79
percent, and we saw that 46 percent of
non-commercial trials recruited their
patient within the first 30 days, and
this was a little lower with 33 percent
for commercial studies, and finally just
to give you an idea from a commercial
point of view, we had over 1500
commercial studies that were open on our
portfolio, so we were supporting over
1,500 trials last year, and this was
 from over five hundred and
thirty different sponsor company,
and managed by 113 different CROs. So
those are the facts and figures about
who we are, and how much research we've
been supporting, but but how do we
actually support the life science
industry with their clinical trials? Well
we do this through our Study Support
Service. This is a series of tools and
support available at completely no cost
to the life sciences industry and it's
applied through a single online portal
with the link available there. The Study
Support Service covers everything from
early contact and engagement, where we
can discuss your study and advise on a
plan of action for what support would be
useful -
this could include connecting you with a
KOL and take your right through to
supporting you to recruit that final
participant onto the trial. After the
early contact and engagement piece we
have three core feasibility offerings
which can be selected singly, or in any
combination, and represented on this
slide. On the left hand side firstly is
the Early feedback Service, this as the
name would suggest, is a review of your
synopsis or draft protocol by our
clinical specialty group as mentioned
earlier. What they will do is assess the
viability and deliverability of the
proposed trial in the UK - it looks at
whether the study is compatible with UK
practice, whether it's in the right care
setting to start, with what type of
research sites would be able to deliver
it, and if investigators would be
interested, and then if participants will
be keen to take part in the study based
on your trial design. Now this service
takes two working weeks and it's a
really good starting point to introduce
you to some to some clinicians to work
further on a study design, or to
potentially keep in mind to be
prospective PIs in the future. The next
two services also assess your study's
eligibility for the portfolio if you've
already selected your sites to run your
trial at then the Site Intelligence
service is the one for you. What we do is
optimize delivery of your trial through
local checks at those sites to
complement the work you've already done,
and ensure the support is in place to
assist with these sites throughout the
duration of the trial. And finally on the
right hand side we have Site
Identification -
this is a UK-wide scan to find
interested sites, and return feasibility
questionnaires from them.
These feasibility questionnaires will
assess site level capacity and
capability. Each site will answer
questions giving you information on the
number of competing trials they're
currently undertaking, and when they're
due to finish, what staffing and
infrastructure they have in place, what
their anticipated setup times are, how
they've performed in recent trials (to
give you an idea about capability), and
they'll give you an idea based on their
numbers in clinic and on their databases
to how many participants they think they
could recruit onto your trial within a
given time frame. As you can imagine,
there's a couple more steps involved in
this so this service takes three working
weeks. As I mentioned with the the site
level services, if the study is eligible
and feasible it will be brought onto
the Clinical Research Network Portfolio.
Now we've recently introduced a new
service called 'Patient Engagement in
Clinical Development' an exception for
this is it is in fact the only
service which is not free, but it
operates at a full cost recovery model
because there are a number of costs
incurred along the way. What this service
is, is a facilitation of a meeting
between an appropriate patient advocacy
group with the study team to discuss the
trial in detail. So whether this is to
get feedback on your travel design, to
get feedback on your trial documentation
such as patient information sheets, or inform consent forms, or it may be that you
just want to sit down with the patient
group to talk about their disease and
the progression, and their experience of
living with that disease, and what
actually would make them consider taking
part in a clinical trial perhaps long
before you've actually put pen to paper
and discuss the study design, but you
want to get a better understanding of
that disease. So this survey
helps to ensure the patients are
considered at an early stage of study
design. What we want to make sure is that
patients are considered and protocols
are written around their needs, and
around their thoughts, and really what
you're likely to get from this is an
increase in patient recruitment and
retention moving on from feasibility for
studies in the setup phase. We have a
series of tools available here in the UK
to support rapid setup of your trial: we
have a single submission portal for
gaining hospital permissions through the
HRA (or Health Research Authority) which
is applied for in tandem with your
ethics approval request. It's a kind of
do want and share model so you'll only
need to fill in the form once even if
you have multiple sites participating. We
also support through streamlining and
increasing the transparency of the
costing and contracting process.
Regarding the costing we have
developed an interactive costings tool.
This is an electronic platform which is
accessed through the same route as the
feasibility services, and it provides
transparent pricing method to cost out
your clinical trial. This is designed to
speed up and simplify multi-site study
setup because resource requirements
negotiated at a lead site, then validated
by the NIHR, are singular and apply to all
participating sites. The idea is that we
want to get your site set up as quickly
as possible so they can begin 
recruiting participants. We also have
model clinical trial agreements that are
available, and these are here to support
quick setup in the UK. These are standard
contracts that are accepted across the
whole of the NHS in the UK eliminating
the need - when used unmodified - for
lengthy legal review at each
participating site. There is also support
available should you encounter any
delays at any of your sites during the
setup phase. This is delivered through
our Local Clinical Research Network
teams who can identify delays and
blockages that may be slowing down
getting your site up and running, and
what we'll do is get them back on track
if we can.
Once your study is open to recruitment
we support the delivery to ensure it has
the best chance of enrolling the target
number of patients within a timeframe
you've given. We have a research ready
workforce numbering over 10,000 embedded
within the NHS to support recruitment to
the studies we support. We also provide
GCP training to all of these staff
supporting the delivery of the trials.
What we do with your study once it's up
and running is performance manage it. We
have local and national delivery teams
that will be proactively tracking
recruitment data on an almost live basis
to assess the performance of individual
sites, and the study as a whole. If
recruitment falls behind schedule
we're able to support by identifying
what the issues are, and coming up with
solutions to alleviate them, and we can
do this through utilizing our clinical
specialty group and our local clinical
research networks on the ground.
So in summary, over the last ten years,
the UK's Clinical Research environment
has changed through the strong
government commitment and the operation
of the National Institute for Health
Research. It has improved drastically and
it continues to do so to ensure that the
UK is globally unique and a world leader
at the cutting edge of delivering
healthcare research. The NHS is
absolutely open for business and - through
the support of the NIHR - can deliver
on all types of research, whether that's
experimental innovative trial design,
clinical evaluation for a new technology,
or a large global Phase three, or perhaps,
a real-world evidence trial. So I suppose
all that left to say is thank you very
much for listening, and please do get in
touch via the details on these slides if
you have any questions, or you want to
talk to one of the team about a
prospective trial you have in mind and
how we might be able to support, please
do. Once again thank you very much.
 
