NIHR Research Design Service

NIHR Research Design Service
London
Professor Azeem Majeed
Department of Primary Care & Public Health

Research Design Service (RDS)
 A national network of support services;
REGIONAL RDS
North East
North West
Yorkshire and the Humber
West Midlands
East Midlands
East of England
South West
South Central
London
South East
 Supporting those who are putting together
research grant applications for national peer-
reviewed funding streams

 We provide free design and methodological support to health
and social care researchers who are developing applications to
NIHR and other national, peer-reviewed funding programmes.
 Access RDS London support:
 Complete our online support request form to request
individual advice or a consultation
 Visit our drop in sessions around London to discuss
emerging ideas for research with our advisors
 Guidance and resources on our website
 Attend our events and seminars
Research Design Service London

 Professor Azeem Majeed (Primary Care and Public Health)
 Dr Victoria Cornelius (Imperial Clinical Trials Unit)
 Dr Laura Vanderbloemen (Senior Research Adviser)
 Ms Hilary Watt (Statistician)
 Dr Roger Newson (Statistician)
 Dr Shikta Das (Statistician)
 Dr John Lee (Economist)
 Ms Kimberley Foley (Research Adviser)
Your Local RDS Team

Our expertise
Local RDS centres: Teams of advisers with a
wide range of methodological expertise
o Statistician
o Health economist
o Social scientist
o Health psychologist
o Epidemiologist
o trial design
o qualitative research methods
o Patient Public Involvement

Our aim
“Increase the volume and
proportion of high quality research
grant applications”

Our role
Provide project specific guidance
and expertise on study design
and health research methods.
Free of charge

 Much more than research design…
 Help identify most suitable funding stream
Our support
 Support teams in working more collaboratively
 Advise on patient and public involvement
 Help get the narrative right
 Advise on training and development plans
 Interview preparation / mock interviews
 Help interpret feedback, support resubmissions

Who can we help?
Those with little experience of research
Those targeting a resubmission
Applicants with experience of
submitting funding applications
Clinicians eager to exploit ideas or
observations
Fellowship applicants
Those requiring advice on study design

Access to the service
Online:
 Through our website
 Simple online support request form
 Greater range of online resources
www.rds-london.nihr.ac.uk

Access to the service
Outreach:
 Regular ‘drop-in’ sessions
across London
 Events / clinics aligned with NIHR funding calls
 Supporting local NHS Trust R&D events
 Presentations to therapeutic communities and
research groups

Delivering the service
‘Primary
care’
Initial
review
feedback
Focuses on the
‘big’ questions,
PPI.
All important
triage step
‘Secondary
care’
Specialist
input
Sample size,
methods for
economic
evaluation, mixed
methods
approaches etc
‘Tertiary
care’
Facilitating
additional
support
Links with Trust
R&D, CTUs and
other established
research
networks
Online
resources
Researchers
guides. Links
RDS insights,
checklists, tips
‘Self
care’

Adding value
NIHR SAF feedback
99% of researchers would recommend using RDS
98% say we improve the quality of their applications
97% are satisfied with the service

A record of achievement
Between July 2009 and July 2016:
 431 successful RDS London supported studies;
total award value in excess of £170m

When should I contact RDS?
 As early as possible
 Ideally at least 3 months
ahead of submission deadline
 Need 2-3 months for really
good input

Sources of funding for research

Sources of funding
MRC (approx £500m per annum)
 Tends towards ‘basic’ or ‘discovery’ research
Wellcome Trust (approx £500m per annum)
 Mainly biomedical, also medical history and humanities
Medical charities (approx £500m per annum)
 Mainly disease-based
ESRC (approx £200m per annum)
 Social science projects
 Not interested in projects with too much ‘health’ in them
NIHR (approx £1 billion per annum)
 Funds programmes, projects, fellowships

www.nihr.ac.uk/publications/
NIHR funding for research
Information about NIHR’s research
funding and career development
opportunities

Basic research,
preclinical studies & proof
of concept
Phase II: early
evidence of
clinical efficacy
Single centre trials located
regionally
Phase III/IV: multicentre
trial; clinical & cost
effectiveness of intervention
Health Technology
Assessment (HTA)
Evidence on quality,
accessibility & organisation of
health services
Evaluation of public health
interventions (non-NHS)
Translational development of
technologies with potential for
commercialisation (may have
industry partners)
Efficacy & Mechanism
Evaluation (EME)
Invention for
Innovation (i4i)
Programme Grants for Applied Research
(PGfAR)
Also Programme Development Grants (PDG)
Public Health Research
(PHR)
A simplified outline of NIHR funding programmes
Invention
Teams of leading researchers
with an interrelated group of
high quality projects focused
on a coherent theme (PDG is
preparatory work for PGfAR)
Medical
Research
Council
Evaluation
Research for Patient
Benefit (RfPB)
Therapies, tests, procedures,
screening, devices, drugs,
interventions, etc.
Health Services & Delivery
Research (HS&DR)
Adoption

Contact the NIHR co-ordinating centre for your programme:
 Central Commissioning Facility (CCF)
o Research for Patient Benefit (RfPB), Programme Grants (PGfAR and
PDG), Invention for Innovation (i4i)
 NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)
o Health Technology Assessment (HTA), Efficacy and Mechanism
Evaluation (EME), Health Services and Delivery Research (HS&DR),
Public Health Research (PHR)
 Trainees Co-ordinating Centre (TCC)
o Fellowship schemes
NIHR funding programmes

General Points:
 Applications submitted on a Standard Application Form (SAF)
NIHR funding programmes
 Outline and Full applications for most NIHR funding streams.
 Fellowship schemes are single stage.
 Multiple calls for proposals each year
 Researcher-led, commissioned and themed calls
 Independent peer review, then assessment by funding committee
 Feedback is given, no lobbying but resubmissions are allowed
 Eligibility rules vary for NHS / HEI applicants

Efficacy and Mechanism Evaluation (EME)
Overview:
 Bridge the gap between preclinical study and evidence of clinical efficacy
 Proof of concept in humans – starting point
 Supports early phase trials in an ideal setting
 Outcome – clinical efficacy. Surrogates OK.
 Mechanistic studies encouraged, but optional
 Remit includes evaluation of small molecules, biologics, psychological
interventions, diagnostics, medical devices
 Treatments to prevent disease are also included
 Collaborative working between NHS, academia and Industry (2/3)
FUNDING DEADLINES - Researcher led: 15 March 2016 July 2016 Nov 2016

Efficacy and Mechanism Evaluation (EME)
Example:
Phase II randomised controlled trial to determine the efficacy of an IL-1
receptor antagonist to treat those with pustular psoriasis compared with
placebo
 Proof of Concept – 7 patients with pustular psoriasis showed
complete resolution with IL-1RA
 Studying efficacy (n=64 in each arm of the trial) of a re-purposed
intervention (IL-1RA)
 Exploring a novel scientific principle that IL-1 over-production is
treatable
 Using mechanistic studies to determine whether gene mutations
are associated with treatment outcome

Research for Patient Benefit (RfPB)
Overview:
 Funds projects that are regionally focused (unique feature)
 Funds projects into everyday practice that address issues of importance
to the NHS
 Trajectory to patient benefit needs to be explicit
 £350K limit - research with clear, close trajectory to patient benefit
 £250K limit for feasibility studies (for a future clinical trial)
 £150K limit for ‘higher risk’ developmental / exploratory studies
 Good option for investigators looking for their first grant
FUNDING DEADLINES - Researcher led: 23 March 2016 July 2016 Nov 2016

Research for Patient Benefit (RfPB)
Example:
 Single blind randomised controlled trial using hot water bottle to
provide evidence that local heat pre-conditioning can reduce skin
necrosis and to assess the feasibility (recruitment, retention, incidence of
necrosis) of undertaking a large multicentre trial.

Health Technology Assessment (HTA)
Overview:
 Evaluates a wide range of ‘technologies’ delivered within NHS
 ‘Technology’ needs to be fully developed and defined
 Often a pragmatic multi centred RCT
 Supports projects that study effectiveness / cost effectiveness
 Outcomes need to measure health gain and matter to patients
 Remit includes interventions to promote health, prevent or
treat disease, improve rehab or long term care. Includes drugs,
devices, procedures, settings of care and screening.
FUNDING DEADLINES - Researcher led: 8 April 2016 10 Aug 2016 30 Nov 2016

Health Technology Assessment (HTA)
Example:
A phase III randomised controlled trial of the effectiveness of anti-
inflammatory treatment on eye surgery in those with open globe
trauma, compared to standard treatment
 The study built upon two pilot studies that demonstrated clinical efficacy
and feasibility of a large scale trial
 Multicentre study (20 specialist eye units, typical of NHS care of ocular
trauma), n = 302, duration = 4 years
 Primary outcome = capacity for eye to see fine detail at 6 months
 Cost effectiveness analysis

Public Health Research (PHR)
Overview:
 Focuses on evaluating effectiveness / cost effectiveness of public health
interventions that are outside of the NHS (complements HTA)
 Evaluation of non NHS interventions intended to improve the health of
the public, prevent disease and reduce inequalities.
Example:
A randomised controlled trial and economic evaluation of a community-
based physical activity intervention to prevent mobility-related disability
for retired older people.
FUNDING DEADLINES - Researcher led: 4 April 2016 Aug 2016 Dec 2016

Health Services and Delivery Research (HS&DR)
Overview:
 Funds research to produce evidence on the quality, accessibility and
organisation of health services. This includes evaluations on how the
NHS might improve the delivery of services, research on implementation
and knowledge mobilisation
Example:
 Reorganising specialist cancer surgery: a mixed methods evaluation.
What is the impact of centralising specialist cancer surgery on provision
of care? What is the impact on patient experience, choice and
continuity of care? What is the impact on ways of (staff) working?
FUNDING DEADLINES - Researcher led: 14th Apr 2016 Aug 2016 Dec 2016

Invention for innovation (i4i)
Overview:
 Supports research and development of innovative healthcare
technologies, which have potential for commercialisation and acceptance
within the NHS (e.g. medical devices, implantable devices and in vitro
diagnostics)
 Supports projects through prototype and commercial development to
introduction and adoption in the NHS
 Supports projects that develop technologies from other sectors that
could have an impact in healthcare
Example: Novel zinc bioglass coatings to eliminate infections
associated with orthopaedic wires and pins. Testing the feasibility
of using biodegradable zinc glasses to reduce infections.
FUNDING DEADLINES - Researcher led: 13 Jan 2016 May 2016 Sept 2016

Programme Grants for Applied Research (PGfAR)
Overview:
 Funds programmes of applied research (projects / workpackages linked
with a clear theme and where combination gives added value)
 Prestigious awards for leading researchers who can demonstrate an
impressive track-record of achievement in applied health research
 Funds projects that are a priority for the NHS that require a
multidisciplinary approach (typical input from clinical, health economics,
statistics, qualitative, health psychology backgrounds)
 Target Programme Development Grant (PDG) for addressing limitations
of a future PGfAR application (£20-100K over 6-18m)
FUNDING DEADLINES - Researcher led: 6 Apr 2016 27 July 2016 Dec 2016
FUNDING DEADLINES - Researcher led: 8 Mar 2016 22 July 2016 Nov 2016

NIHR Themed calls
 Issued to address an identified health challenge or government priority
 Previous calls have focused on dementia, very rare diseases, surgery,
primary care interventions, antimicrobial resistance, long-term
conditions in children and young people, and mesothelioma.
 All NIHR research programmes take part
 NIHR infrastructure joins together to support the call
 Not short-term initiatives, but act as pump-primers that draw
attention to national priorities and promote greater research activity
 NIHR funding programmes are always interested in receiving
applications (as part of their usual researcher-led workstreams) even
after the initial promotion of the theme has ended.

Prevention and treatment of obesity
Research into the evaluation of interventions or services for the
prevention and treatment of obesity in adults and children.
Issues of particular importance for this call include the prevention
of type 2 diabetes and increasing levels of physical activity.
NIHR Themed calls
FUNDING DEADLINES – EME, HTA, HS&DR, PHR, i4i, PGfAR
RfPB
6th Apr 2016
23rd March 2016

NIHR commissions research that addresses specific topics/themes.
 Important questions (for NHS) agreed by prioritisation panels.
 Priority or gap in knowledge has already been identified by
policy/decision makers
 Applications are assessed on how well they fit the commissioning
brief.
NIHR Commissioned calls

Fellowship schemes
Overview:
 Personal awards / institutional awards covering salary, training
and development costs and research costs.
 A person with potential and trajectory for their career
 A good project with aims of the funder
 A tailored training/development package
 Suitable institution and supervision
 Pre-doctoral, doctoral, post-doctoral, senior/pre-chair, chair

Advice on good writing style
• Many style guides are
available
• Pick one that you like
• I generally recommend
“Medical Writing: A
Prescription for Clarity”
• “From Creation To Chaos:
Classic Writings in Science”
Edited by Bernard Dixon

Some basic points about writing style
• Spend time acquiring a good, readable style of
writing
• Be clear and concise
• Avoid using too many long sentences
• When you have the choice of two words, use
the simpler one
• Use active rather than passive verbs
• Avoid using colloquial language & cliches

What did Winston Churchill say?
• He said “I have nothing to offer but blood, toil,
tears and sweat”
• He did not say “I have nothing to offer but the
red liquid that circulates in blood vessels,
exertion, lacrimation and perspiration”
• He said “We will fight them on the beaches”
• He did not say “We will fight them on the
coastal perimeters”

Some examples rewritten
1: In the case of this particular elderly patient hypertensive population, reduction of blood pressure by 18/11 mm Hg was
achieved for a mean duration of follow up period of 4.4 years. However, with regard to overall mortality, there was no effect nor
was there any effect on the incidence of occurrence of myocardial infarction, whether of fatal or non-fatal nature. With respect to
cardiovascular accidents, a reduction in incidence of 42% was encountered, and this was mainly associated with strokes leading to
fatality or serious neurological sequelae. Although it was not significant, cardiovascular mortality was shown to be reduced by
22%.
In these elderly patients with hypertension, blood pressure decreased by 18/11 mm Hg for a mean follow up of 4.4 years.
There was no effect on overall death rates or on the incidence of fatal or non-fatal heart attacks, but there were 42% fewer
strokes, mainly apparent in fatal and major strokes. Deaths from cardiovascular disease decreased by 22%, but this was not
statistically significant.
2: It is possible to speculate that operative intervention would have saved this man’s life. The policy of management was
conservative because of uncertainty as to the cause of deterioration.
An operation might have saved this man’s life, but we did not operate because we did not know why he had deteriorated.
3: Each case has to be managed individually after a full history has been taken, and examination and, where necessary, special
investigations have been undertaken, so that an accurate diagnosis can be made and appropriate treatment selected.
Each case has to be managed individually. A full history and examination and any necessary special investigations will enable
an accurate diagnosis and appropriate treatment.
4: Baby walkers are devices that provide preambulatory infants with postural support in addition to offering them the opportunity
to experience bipedal locomotion. They are intended to simulate independent walking and by so doing, it is argued, encourage
and even accelerate the early acquisition of this skill.
Baby walkers are devices that allow babies who are still at the crawling stage to stand and to practise walking. Some
authorities believe that they speed up the ability of babies to walk independently.
Source: Medical Writing. A Prescription for Clarity

Even the best writers can be rejected

Contact Details
Email: a.majeed@imperial.ac.uk
Twitter: @Azeem_Majeed
Facebook: https://www.facebook.com/azeem.majeed
Blog: http://medical-centre.blogspot.co.uk/

Research Design Service London
www.rds-london.nihr.ac.uk
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