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NIHR Research Design Service London
Professor Azeem MajeedDepartment of Primary Care & Public Health
Research Design Service (RDS)
A national network of support services;
REGIONAL RDSNorth EastNorth WestYorkshire and the HumberWest MidlandsEast MidlandsEast of EnglandSouth WestSouth CentralLondonSouth East
Supporting those who are putting together
research grant applications for national peer-
reviewed funding streams
RDS London
Imperial College London
Queen Mary University London
University College London
King’s College London
A successful partnership
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 serviceOutreach:
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. LinksRDS 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 programmesInvention
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
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 programmesInvention
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
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 schemesOverview:
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 rewritten1: 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: [email protected]
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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