Clinical Research Grants Workshop Sources for courses

1
Clinical Research Grants WorkshopSources for
courses?

• Simon Dixon
• Trent Research and Development Support Unit, and
• School of Health and Related Research

2
Objectives

• Describe various funding schemes for applied
  clinical research
• Enable you to target your research proposals to
  the most appropriate scheme
• Enable you to plan your proposals for an
  appropriate submission date
• Provide sources of further information and help

3
Outline

• National Institute for Health Research (including
  Programme Grants, HTA, SDO, RfPB, IIRP and RISC
  schemes)
• Medical Research Council
• Charitable Foundations
• Sources of further help

4
Outline

• Objectives of the scheme
• Preferred methods and topics
• Grant sizes
• Frequency of calls and success rates
• A successful example (where available)

5
NIHR
6
Programme Grants for Applied Research

• Prestigious awards for teams of researchers from
  NHS and academia
• Impressive track record of research
• Support a series of high quality related projects
  and associated infrastructure needs
• Health services research, public health research,
  behavioural research, health economics and
  modelling

7
Programme Grants for Applied Research

• Awards for a maximum of 2m over a five year
  period
• Service support costs and treatment costs are not
  covered
• Annual competition
• Round 2 April Intention to Submit, June outline
  proposals, October full proposals
• Round 3 July Intention to Submit, October
  outline proposals, February full proposals
• Round 4 April, June, October
• No restriction on clinical areas first year was
  an exception

8
Local success

• Improving management of Type 1 diabetes in the
  UK the Dose Adjustment for Normal Easting
  (DAFNE) programme as a research test-bed
• Development of database of DAFNE patients
• Explanatory analysis of DAFNE outcomes
• RCT of insulin pumps within DAFNE
• Development of user participation
• Cost-effectiveness analyses related to 1-3
• 1.6 million over five years

9
Health Technology Assessment (HTA) Programme

• HTA Clinical Trials
• Responsive Funding Stream open calls
• HTA Main Programme
• Topics identified by NIHR with a strict
  definition of the research question
• Primary research and evidence synthesis
• Other priority areas, currently Emergency
  Medicine, Pre-hospital Care and Trauma

10
Health Technology Assessment (HTA) Programme

• To assess the effectiveness and
  cost-effectiveness of health technologies in, or
  likely to be in, NHS practice
• Pragmatic studies real world setting,
  wide/representative eligibility, and health based
  outcomes (e.g. QoL)
• Some evidence of efficacy exists
• No pilot or phase II studies
• RCTs are the mainstay
• Other study designs, e.g. diagnostic tests

11
Health Technology Assessment (HTA) Programme

• No maximum limit on awards, and increasingly no
  maximum time limit
• Service support costs and treatment costs are not
  covered
• HTA Clinical Trials accepted on an ongoing basis,
  with the Board meeting twice per year that
  consider outlines and full proposals
• HTA Main Programme makes calls once or twice per
  annum, with 3 months lead to outline, and 2
  months to full proposal

12
Health Technology Assessment (HTA) Programme

• HTA Main Programme
• 5-10 outline bids
• 2-3 shortlisted
• 1 funded

• HTA Clinical Trials

13
Local success

• Cluster RCT of cognitive behavioural therapy for
  patients with insomnia and long-term use of
  benzodiazepines
• 200,000, three years, n209, 23 general
  practices
• This is very cheap. HTA is now amenable to
  better resourced trials, e.g. with CTRU support,
  1M is not uncommon
• Patients followed-up for one-year, with measures
  of sleep, drug use, QoL and costs
• Used a previously developed schedule of CBT
  counselling

14
Service Development and Organisation (SDO)
Programme

• To produce research evidence directed at SDO and
  the application of that evidence in practice
• Mixed methods RCTs, literature reviews,
  qualitative studies, other quantitative HSR
• Multiple objectives
• Very strong emphasis on user engagement
• Calls do not come with a strict definition of the
  research question

15
Service Development and Organisation (SDO)
Programme

• Calls 2-3 times per annum, and relate to research
  themes
• Current themes patient- and carer-centred
  services, workforce, evaluating models of health
  care delivery, change management, studying health
  care organisations, research methods
• No maximum limit on awards although a notional
  overall figure for the call is sometimes given.
  Typically no maximum time limit
• Two stage commissioning process with 3 months
  lead to outline, and 2 months to full proposal

16
Local success (1)

• The impact of workforce flexibility on the costs
  and outcomes of older peoples services
• 300,000, three years, literature review and
  reanalysis of existing datasets to examine skills
  mix issues
• Prospective study of workforce skills mix and
  dynamics on patient costs and outcomes in around
  20 community and intermediate care services
• Conjoint analysis of patient preferences for care
  (quantitative interview based methodology) in 200
  patients

17
Local success (2)

• Cluster RCT of chest pain observation units
  (ESCAPE)
• 480,000, three years, 14 hospitals
• Patients followed up for six months using routine
  data and a postal questionnaire covering
  satisfaction, quality of life and costs
• Qualitative evaluation of acceptability using
  semi-structured interviews of patients
• Organisational evaluation involving
  semi-structured interviews and self-complete
  questionnaires to identify the processes that
  influenced CPU development

18
Research for Patient Benefit (RfPB)

• Intended to support research which is related to
  the day-to-day practice of health service staff
• Capable of showing a demonstrable impact on the
  health or health care of service users (quickly)
• User engagement encouraged
• Inclusive of qualitative and quantitative methods
• Pilot studies eligible, but not laboratory-based/
  basic science, literature reviews, audit,
  surveys, needs assessment, or technology
  development

19
Research for Patient Benefit (RfPB)

• Awards up to 250,000 over a 3 year period
• Response mode no restriction on topic or
  clinical area
• Rolling programme three decision dates per year
  (October, February, June)
• Accept submissions at any time, for consideration
  at next available committee
• Two staged submission with intention to submit,
  and full submission
• Two or three funded from the first round (across
  YH)

20
Invention for Innovation Research Programme (IIRP)

• Brings together two existing programmes New and
  Emerging Applications of Technology (NEAT) and
  Health Technology Devices (HTD) programmes
• Details are sketchy as the schemes arent yet
  fully merged, but for NEAT..
• The aim is to produce innovative health care
  products and interventions
• The programme does not fund assessments of fully
  developed products or interventions with a
  history of use in the NHS

21
Invention for Innovation Research Programme (IIRP)

• Response mode, and cover all topic areas although
  projects addressing National Priorities are
  particularly welcome
• Full projects with an approximate budget of 300K
  over a 36 month period
• Feasibility studies which last 6-12 months with a
  budget of up to 70K
• Full projects follow a two stage peer-reviewed
  process
• Feasibility studies follow a single stage
  non-peer reviewed process

22
Research for Innovation Speculation and
Creativity (RISC)

• RISC awards are intended for speculative, novel
  proposals that are unlikely to gain support
  during traditional peer review processes
• Complementary to RfPB as it provides a
  response-mode funding stream for applications
  that are too speculative for RfPB
• Encouraged to search for traditional funding on
  completion so as to develop the idea

23
Research for Innovation Speculation and
Creativity (RISC)

• There is an annual competition which is managed
  nationally
• Single stage process, with deadline for current
  round 29th May 2007 and results due on the 16
  July 2007
• The maximum grant will be 100,000 per project
• At full capacity they intend to make 50 awards
  each year
• Awards will normally be for 12-18 Months in
  duration

24
MRC
25
Project grants

• Very flexible and is the main scheme for
  supporting biomedical science in UK universities
  and NHS Trusts
• Single studies and broader-based research
  programmes
• Awarded for up to five years, but those of two
  years or less are for proof of principle or pilot
  work only
• Research Grants do not cover research involving
  randomised trials of clinical treatments
• Deadlines depend on which research board is
  relevant to your bid. Typically 3 per annum.
• Success rate 20

26
Trial grant

• High quality studies blue ribbon - on the
  comparative efficacy and effectiveness of
  interventions
• Not focussed on confirmatory studies or trials of
  incremental modifications to existing health
  technologies
• Response mode, with three deadlines per annum
  Outline bids in August, December and April, and
  invited full bids in January, May and September.
• Success rate currently 50 (presumably for
  invited full proposals).but, currently
  underutilised due to uncertainty over its future.
  Only 4 considered at the last Board

27
Charitable Foundations
28
BUPA Foundation

• Single projects or programmes up to 3 years, 1.5
  million nationally per annum
• Areas are surgery, preventive health,
  information and communication, mental health in
  older people and health at work
• July and October deadlines
• Themed grant programmes
• Current year (closed) was New roles for health
  professionals in addressing public health needs

29
Others

• The Health Foundation (formerly PPP)
• Various funding schemes
• Dunhill Medical Trust
• Elderly care
• Plus disease specific charities

30
Summary

• Growing number of sources for research funding
• Response mode funding is available for innovative
  and established, small and large, RCT and
  non-RCT,
• It is a very good time to put bids into the MRC
  Trial Scheme and HTA response mode scheme
• Calls for proposals across various NIHR schemes
  happen 3-4 times per annum
• Non-specific charitable, and disease specific
  charitable foundations also available
• Targeting your research at the most appropriate
  scheme is the easiest way to increase your chance
  of success

31
Summary

• Help is available from local Universities and
  Units
• Trent RDSU funded by DH to support researchers in
  the NHS
• Expertise in a range of methodologies
  observational studies, statistics, health
  economics, systematic reviews
• Links with the Sheffield Clinical Trial Research
  Unit (CTRU)
• Also help with more specialised searches for
  funding
• Another source of funding information is RD info
  (information from 1381 Funding Bodies offering
  5518 different awards)

32
Sources and further information

• http//www.nihr.ac.uk/
• http//www.mrc.ac.uk/index.htm
• http//www.rdinfo.org.uk/
• http//www.trentrdsu.org.uk/
• http//www.shef.ac.uk/ctru/
• A copy of the handouts will be made available on
  the STH RO website

33
Trent RDSU Advice Clinics

• Stats clinics (most popular, so book early)
• Fortnightly. Next available clinics 5th, 19th
  June, 3rd, 17th July
• General advice clinics
• Monthly. Next available clinics 12th June, 10th
  July
• Health economics clinics
• Fortnightly. Next available clinics 5th, 19th
  June, 3rd, 17th July
• Book via RDSU website

34

• STH Research Department Advice Clinics
• Stats Clinics
• Wednesdays 12.30-13.00 and 13.00-13.30
• Fridays 13.30-14.00 and 14.00-14.30
• To book contact Marie Lacey on 13916 or
  marie.lacey_at_sth.nhs.uk