nihr funding opportunities eme and hta programmes · pdf file · 2015-09-07nihr...
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NIHR funding opportunitiesEME and HTA programmes
Dr Sarah PuddicombeAssistant Director
NIHR Evaluation Trials and Studies Coordinating Centre (NETSCC)
• Overview of NIHR• EME and HTA Programmes• Funding process • What makes a good application• How to engage with NIHR
– Submitting research suggestions– Reviewing priorities and funding applications
Overview
The NIHR Health Research System
The central role of NIHR research in the innovation pathway
INVENTION EVALUATION ADOPTION DIFFUSION
Biomedical Research Centres
Basic Research
National Institutefor Health Research
This pathway covers the full range of interventions - pharmaceuticals, biologicals, biotechnologies, procedures, therapies and practices - for the full range of health and health care delivery -prevention, detection, diagnosis, prognosis, treatment, care.
Patient Safety Translational Research Centres
Research for Patient Benefit
Programme Grants for Applied Research
Health Technology Assessment
Invention for Innovation
Collaborations for Leadership in Applied Health Research and Care
Dissemination Centre, Cochrane, TARs
Development Pathway Funding
Public Health Research
Health Services and Delivery Research
Efficacy & Mechanism Evaluation
NHS Commissioning Board and Clinical Commissioning Groups Commissioning
National Institute for Health & Care Excellence Guidance on Health & HealthcareNHS Supply Chain Support for Procurement
NHS Evidence Access to EvidenceInnovationAcademic Health Science Networks
Patient CareProviders of NHS Services
Clinical Research FacilitiesExperimental Cancer Medicine Centres
Horizon Scanning Centre
Centre for Surgical Reconstruction & Microbiology
Biomedical Research Units
MedicalResearch Council
Healthcare Technology Co-operatives
Research Schools
• Research with the capacity to improve patient and public outcomes and NHS services
• Multiple methodologies (not only RCTs)
• Not– Discovery science– Work involving animals or animal tissue
What is applied research?
Which funding programme?
http://www.nihr.ac.uk/documents/about-NIHR/NIHR-Publications/Funding-Opportunities-Booklet.pdf
Managed translational pathway
Overview of NETS programmes- since 2012
NETS
Public Health Research (est 2008)Public health interventions outside the conventional health service.Trials in community settingsNatural experimentsEvidence synthesis and primary research
Health Technology Assessment (est 1993)Pragmatic,Clinical and cost effectivenessMainly quantitativeMainly evidence synthesis and RCTs or appropriate study design
Health Services and Delivery Research(est 2012) Models of delivery, systems research, patient experienceMainly qualitative or mixed methods
Efficacy & Mechanism Evaluation (est 2008)Funded jointly by the Medical Research Council and NIHRTranslational research brokerMainly devices and pharmaceuticalsEfficacy (e.g phase 2b) and mechanistic studies
Systematic Review(est 2012)Production and updated SRs supported by core funding UK Cochrane Centre, Cochrane Review GroupsCRD/NIHR DC and twofunding streams (CPG and CIA)
www.nets.nihr.ac.uk
Commissioned and researcher-led callsFull and appropriate funding, no upper limit (except SR)
Our approachNeeds-led
• We assess questions important to the NHS and other information consumers, and in what priority they should be answered.
Science-added• We ask does the proposal meet the scientific quality
we insist on, and how can we support the delivery of quality.
Value for money• Assessment of need and scientific support maximises
the relevance and benefits to patients, NHS and decision makers
Efficacy and Mechanism Evaluation Programme
Aim:• Support excellent clinical science with an ultimate view to improving
health or patient care
Dual Approach:• “Science driven” – examine the efficacy of a technology intervention
(i.e. pharmaceutical, diagnostic test, surgical or psychological therapies, or public health measures) and/or explore its mechanisms of action
• Clear patient focussed outcomes in areas of need for health care research
Efficacy and Mechanism Evaluation Programme
• Provide definitive evidence of efficacy of healthcare interventions, including the size of the effect and safety
• Add significantly to understanding of disease mechanisms• Break new ground – new scientific or clinical principles• Include development or testing of new methodologies• Include validated surrogate markers as indicators of outcome• Include laboratory studies as part of the main study, if relevant to the
EME remit
EME will support clinical trials and evaluative studies in patients that:
Efficacy and Mechanism Evaluation Programme
• Confirmatory studies • Studies to identify previously unknown biomarkers • Incremental modifications or refinements of existing technologies• Proof of concept studies
• Confidence in Effect
• Global Health studies
• Any research involving animals
EME does not undertake:
Study of Tolerance to Oral PeanutDr Pamela Ewan & Dr Andrew Clark, University of CambridgeOral immunotherapy can induce tolerance to peanuts in peanut allergic patients
Remote ischaemic preconditioning in renal transplantationProfessor Raymond MacAllister, University College LondonCan RIPC improve renal function after transplantation
A randomised double-blind placebo controlled Phase 2B clinical trial of repeated application of gene therapy in patients with Cystic FibrosisProfessor Eric Alton, Imperial College LondonEffectiveness and safety of monthly aerosol administration of CFTR into lungs of CF patients
EME Funded Studies
Purpose and Remit• To deliver high quality research information on the effectiveness,
costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS.
What is HTA?• The term includes all interventions used to promote health, prevent
or treat disease, improve rehab or long-term care including drugs, devices, procedures, settings of care and screening.
Evaluation Trials and StudiesCoordinating CentreHTA Programme remit
Typical HTA randomised controlled trial:
o Multidisciplinary and multi-centreo Effectiveness and cost-effectiveness (usually estimate £/QALY)o Pragmatic and externally valido Median number of patients = 700 (Range of 15 to 75,000 across
current projects)o Average duration ~4 years and £~1.2 mo Protocols available on web site with costs
Types of studies funded:o randomised controlled trials and non-randomised trialso stand-alone pilot and feasibility studies (where there is evidence
they will lead to a full trial)o cohort studies (retrospective or prospective)o adaptive and efficient study designs, methodological studieso evidence synthesis and modelling studies
Treatment of severe ankle sprain: a pragmatic randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trialProfessor Matthew Cooke and Professor Sallie Lamb, University of Warwick
CRASH2 Trial, a large randomised placebo controlled trial among trauma patients with significant haemorrhage of the effects of an antifibrinolytic treatment on death and transfusion requirementProfessor Ian Roberts, London School of Hygiene and Tropical Medicine
PD MED, A large randomised assessment of relative cost effectiveness of different classes of drugs for ParkinsonsDr Richard Gray, University Oxford
HTA Project Examples
Topic identification - for commissioned calls
• External Engagement (Royal colleges, clinical networks, speciality groups, charities)
• Stakeholder engagement (e.g. DH, NICE, patient organisations, National Horizon Scanning Centre)
• Panel members/ Chairs (suggestions and ID activities at panels)
• James Lind Alliance PSPs• Literature searches ( publications/NIHR final reports)• Data base scanning (Cochrane, DARE, DUETS)• Webform for public and professional suggestions:http://www.nets.nihr.ac.uk/identifying-research/make-a-suggestion
Potential EME topics
Commissioned- Potential Calls
Check out the pipeline of potential topics for future commissioning(in ~6-12 mths) on our programme funding pages
Potential HTA topics
Funding Streams• Commissioned workstreams
– Identification of clinical uncertainties by the research programme– Start with an assessment of importance to the NHS– Topics are refined and prioritised by people with expertise in the field, and
commissioning briefs are advertised– Applications are assessed for compliance with the commissioning brief,
scientific quality, feasibility and value for money
• Researcher-led workstreams– Open calls for researchers to apply for funding for their own questions – Applications are prioritised in terms of NHS need in a process similar to that
in the commissioned workstreams– Applications are then assessed for scientific quality, feasibility and value for
money
Efficacy and Mechanism Evaluation Programme
Types of Research
Primary Research;Clinical efficacy of interventions
Primary Research;Clinical efficacy of interventions
Who defines the question?
EME Programme
Researcher
Frequency Per year
3 submission deadlines
Continuous with 3 submission deadlines
Researcher- led
Commissioned
Efficacy and Mechanism Evaluation Programme
• Research areas identified using a broad range of sources • Previous calls include:
Diagnostics to support stratified medicineNovel imagingCOPDPancreatitisRetinal diseasePre-eclampsia
• Calls pre-advertised for 6-12 months before a commissioning brief is published for each new call
• Webinars held for each commissioned call• Application Process – 3/yr (several calls open at once) • Check the website: www.nets.nihr.ac.uk/funding/eme-commissioned
Commissioned work stream
Efficacy and Mechanism Evaluation Programme
• Need to be fully worked up and embedded in the main study
• Should be hypothesis driven with a feasible research question
• Should aim to advance scientific understanding of the disease mechanism or the mechanism of action of the treatment
• Discovery of new biomarkers is not within the remit of the EME Programme.
Mechanistic studies – optional but encouraged in all efficacy studies
Efficacy and Mechanism Evaluation Programme
In addition:• Studies must utilise patients or samples from current or completed
NIHR-funded or NIHR-managed studies in any setting.• The research relevant to the intervention and outcomes proposed
by the original study and add significantly to the scientific understanding of the mechanisms of action of the Intervention
• May involve the analysis or reanalysis of previously stored specimens or data, or the collection of new specimens or new data for additional analysis, provided it is obtained from study participants.
Stand alone mechanistic calls for funded NIHR studies
EME funding process
Types of Research
Specific technologyassessment
Primary researchFeasibility & pilotEvidence synthesis
NICE
Researcher
Primary researchEvidence synthesis
Theme from HTAProgrammeQuestion from researcher
Continuous with3 closing dates
Primary researchFeasibility & pilotEvidence synthesis
HTA Programme 3 calls
1-2 calls
Direct referral toOn-contract teams
Who defines the question?
Frequency Per year
Commissioned
Evaluation Trials and StudiesCoordinating Centre
NICE Guidance
Researcher-led
Clinical Evaluation
Themed Calls
Health Technology Assessment
Overview of HTA application processTwo stage process (outline & Full)Pilot in HTA -Short EoI form instead ofoutline application
Panels consider importance/needBoard consider scientific quality, feasibility, host, team and value for money
External peer and public reviewTimeframe submission to final decision:~ 3.5 months Evidence Synthesis (straight to full- one stage)~7.5 months Primary ( outline and full- two stage)
http://www.nets.nihr.ac.uk/funding
Close Programme Call1st July 15 EME 15/48 Researcher-led3rd Sept 2015 HTA 15/57 Researcher-led Expressions of Interest3rd Sept 2015 HTA 15/58 Researcher-led Evidence Synthesis Full24th Sept 2015 HTA 15/39 - Treatment of avascular necrosis of the femoral
head24th Sept 2015 HTA 15/40 - A clinical decision aid to inform the management of
lower urinary tract symptoms in men in primary care24th Sept 2015 HTA 15/41 - Interventions for adults with spasticity due to
Cerebral Palsy24th Sept 2015 HTA 15/42 - Multi-modal retinal imaging for surveillance of
patients with treated diabetic eye disease24th Sept 2015 HTA 15/43 - Extended rehabilitation for older frail people after
acute illness or injury10th Nov 2015 EME 15/73 Markers of early treatment response in non-
cancerous conditions10th Nov 2015 EME 15/74 Novel diagnostics and treatments for irritable bowel
syndrome10th Nov 2015 EME 15/75 Mechanisms of action of health interventions
Evaluation Trials and StudiesCoordinating Centre
• Important to the NHS or addressing an information need• Research focused on patient outcomes and quality of life• Timely and supported by current evidence • Structured to provide clear, well-defined question (PICO)• Provides value for money with realistic costing• Plausible recruitment and retention• Demonstrated PPI engagement at all stages• RDS/CTU engagement (as appropriate)• Good quality plain language summary• Well proof read • http://www.youtube.com/NIHRtv
What makes a good research application?
Tips for success
Commissioned • Check our regular adverts
on hta.ac.uk and eme.ac.uk
• Subscribe to call notifications
• Minimum of 8 weeks to respond to an advert
– You must be quick – the board recognises this
Researcher-Led• Put together a compelling
and robust application to answer an important researcher question
• Submit it when it’s right– It’s better to submit the right
application, than a quick application.
Tips for success
• Read the detailed brief for the call, the Guidance notes and the FAQs www.nets.nihr.ac.uk/funding
• Check application fits within the programme remit www.nets.nihr.ac.uk/faqs/remit
• Check against the existing portfolio of research
http://www.nihr.ac.uk/research/programme-studies.htm
and UKCRN portfolio: http://public.ukcrn.org.uk/search/
• Use online resources Webinars/ help videos: www.nets.nihr.ac.uk/resources/
• Please contact programme secretariat for advice
Efficacy and Mechanism Evaluation ProgrammeIssues commonly discussed by the Board (1)
• Research question – the question needs to be in remit and clearly defined in simple terms, ideally in one sentence
• Importance – of this project needs to be explained
• Justification – needs references or preliminary data
• Patient and public involvement is expected from the design stage through to delivery and dissemination of research
• Multi-disciplinary team – including clinical staff, researchers, statisticians and experts in study design
• Research Design Service/Clinical Trials Unit – consult early
Efficacy and Mechanism Evaluation Programme
• Study design – needs to be optimised to answer the question
• Outcome measures – justify your choice of primary outcome and any secondary outcomes
• Sample size/power calculation – provide enough data to allow the calculation to be repeated
• Recruitment plan – make sure this is credible by including eligible number of patients, drop-out rates and recruitment targets
• Drug dose/side effects – need to be clearly explained for drug studies
• Costs – these need to clearly justified, especially high-cost staff such as clinicians
Issues commonly discussed by the Board (2)
How can I get involved?• Suggest future research topics anytimehttp://www.nets.nihr.ac.uk/identifying-research/make-a-suggestion
• Professional and public contributors welcomed:• Become a reviewerhttp://www.nets.nihr.ac.uk/become-a-reviewer/reviewer-form• Apply for advisory roles openly advertised on website e.g.
Panel member/Board member
• Join our mailing lists for programme and funding bulletins• http://www.nets.nihr.ac.uk/news/bulletins
• For general information on NETSCC and our work– info@netscc.ac.uk or www.netscc.ac.uk
• Always willing to answer questions on remit
• EME Programme– info@eme.ac.uk or www.eme.ac.uk
• HTA Programme– hta@hta.ac.uk or www.hta.ac.uk
Contact details
Evaluation Trials and StudiesCoordinating Centre
Puddicombe Way : A dedication to Mima Puddicombe, OBE. Former Matron of Addenbrookes 1958-1970, who died in 2005. Pictured meeting the Queen in 1962.
Thank you for listeningAny Questions?
Supplementary slides
• Launched 2008• Recognises the crucial role played by CTUs in designing and delivering
quality NIHR research applications and projects• Provides ‘priming’ funding to support CTUs on a 3 year rolling contract and
provides stability to units, allowing expansion and retention of skilled staff• Intended to result in an increased number of high quality research
applications submitted to NIHR programmes• 22 CTUs in England supported to date on rolling contract basis• Funding adjusted according to successful grant applications
Clinical Trials Unit Support Funding
Evaluation Trials and StudiesCoordinating Centre
Success rates
16% EME 2014/15( 1/3 out of remit and 2/3 rejected at outline)18.7 % HTA 2014/15
Expert Review
HTA Research Recommendations ?
Topics
HTA Panel prioritises topic
Methods Group checks design
HTA Prioritisation
Group
Commissioning Board
6 Advisory Panels
Dissemination HTA monograph Peer reviewed
publications Conferences
Research
Proposals received
Vignette developed
Commissioning Brief advertised
Prioritisation Group
DH Funding Approval
– Pieces of research done before a main study– Used to estimate important parameters that are needed to
design the main study– Feasibility studies for randomised controlled trials may not
themselves be randomised– They do not evaluate the outcome of interest; that is left to the
main study
Feasibility studies are:
Evaluation Trials and StudiesCoordinating Centre
• A small scale version of the main study that runs to test whether the components of the main study can all work together
• Focused on the process of the main study, for example recruitment, randomisation, treatment, and follow-up assessments
• An internal pilot is a pilot that may be the first phase of the substantive study and date from the pilot phase may contribute to the final analysis
• An external pilot is one where the date may be analysed but set aside in respect of the substantive study
Pilot studies are:
Evaluation Trials and StudiesCoordinating Centre
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