hello my name is professor Miles Witham, I'm the national specialty lead for the NIHR are
aging clinical research Network I remember of the steering group for the include project the
include project has four core objectives firstly to develop community partner participate research
making sure that underserved groups are embedded in the whole research journey all the way from
priority setting through to delivery and dissemination secondly to provide tailored
training and resources both to researchers as they design studies that are inclusive but also
into those charged with delivering studies on the ground to make sure that we're able to reach and
recruit people from underserved groups thirdly we want to develop infrastructure and systems
to enable us to monitor and deliver studies for underserved groups and finally we want
to work with funders and regulators to remove barriers to the inclusion of underserved groups
in clinical research so how will include work in practice I'll give you an example
from my own specialty which is that of Aging we know that all the people are often not able to
participate in research and that's despite the fact that all the people are at higher risk of
many diseases than their younger counterparts so include project is of highly relevant to my
specialty and we're going to be doing a number of things based on the include framework to try and
improve the participation of all the people in clinical research one of the things that we're
aiming to do is to make sure that older people aren't excluded because of unnecessary inclusion
and exclusion criteria and one of the things we can do there is to use the include framework to
give guidance to researchers but also to ethics committees and funders who will be scrutinizing
applications another example is working with all the people themselves to find out the best way
to approach recruit and retain all the people in clinical studies working with partners across the
NIH our clinical research network particularly at the local livery ethyl through understand
well the best way is to find and recruit all the people into studies locally are an example they
would be working with colleagues in the enrich network of care homes to make sure that we're
able to approach and recruit people living in cabins who again form another serf we'll
be working with the aging national specialty group to develop the infrastructure we need to
support recruitment of older people into clinical studies that means making sure that specialists in
the care of older people such as geriatricians are able to take part as local investigators
giving them the training and support they need to do that role and after while working with
colleagues in other specialties an example for my own practice I've been working with colleagues in
the renal national specialty group for a number of years and we've successfully delivered study
is focusing on older people with kidney disease who again form an underserved group within that
disease area any use of the include framework has to bear in mind that underserved groups are not
only study specific but they context specific even within certain disease areas or certain regions of
the country so understanding whether a group is underserved in a particular area of a particular
disease is important and working with the clinical research network to develop the tools we need to
monitor that an example there being that we are now collecting data on age across the number of
disease areas to make sure that the age profile of patients recruited into studies matches that
we see in clinical practice so putting all of that together we can work with the include framework to
highlight these areas and improve recruitment to clinical trials and other clinical studies for
older people so how will the project outputs from the include project be used to make a difference
I'm going to use the example of Covid 19 here which of course is highly topical what we've
done with the include framework is used that as a template to provide conditions specific advice
and guidance to researchers that's something that we're developing at the moment so we've used the
road map from the include project which describes the points of intervention over the lifetime of a
research project to show how researchers funders ethics committees delivery teams patients analysts
can all combine to successfully deliver coded research that is inclusive and takes account
of the need of underserved groups we know that Covid is not an equal opportunities disease it
disproportionately affects people from black Asian and minority ethnic communities it
disproportionately affects all the people people living with obesity people who are deprived and
people who have multi mobility many different diseases it's more difficult for some groups
to take part in research for Covid 19 because of the lockdown and the restrictions that's placed on
movement that particularly applies to people who have to shield due to other conditions people who
don't have a car or a not otherwise mobile and it's important that research can embrace these
groups as well as those who are more mobile and and who are fitter so the specific guidance that
we have developed goes all the way across the research journey starting with priority setting
for people suffering from Covid through inclusion and exclusion criteria for clinical studies to
make sure that people who are older people who are socioeconomically less well-off people with multi
morbidity or whom have obesity make sure they're not excluded from Covid studies we look at advice
for designing studies to make sure that it's as easy as possible for a broad range of people to
take part in covert research how we deliver that research on the ground which clearly has to be
done in a safe way but needs to make we need to make sure that we don't exclude people or deprive
them of the opportunity to take part then finally through to how we analyze the results particularly
subgroup analyses for people who are at highest risk of bad outcomes from and how we disseminate
the findings as well working in partnership with different communities some of them who are
underserved to make sure that they don't only get the opportunity to take part in research but they
get to hear about the results and influence what happens with those results so what are the top
priorities for an NIHR to address over the next few years in order to advance this agenda that
we have laid out in the include project the first priority is to work with partners amongst all of
our partners within the NIH our clinical research network but also within the wider family of NIHR
are from the funding arms the infrastructure arm such as the PRC's and the arcs as well as the CRN
and the delivery arms we've got other partners that it's key to work with Newcastle University
who have been hosting the include project infrastructure but a broad range of charities
and funders it's key to engage with those but also with regulators such as the HRA and the MHRA and
also with our commercial partners and it's key to bring all of those into the process and to
engage with all of them to understand barriers and drivers to making sure that the included gender is
taken up widely we'll also be working very closely over the next few years with partners across NIHR
are in the Equality diversity and inclusivity initiative to make sure that our messages
dovetail with those and that the impact of the include project is maximized across all aspects of
research and finally and perhaps most importantly the priority is to work with underserved groups
themselves with patients and the public partners in this research process and to bring underserved
groups and researchers together over the longer term so engaging with our colleagues in PPI
II is going to be an absolutely key priority if we're going to successfully make sure that people
from underserved groups have the opportunities they deserve to take part in clinical research
you