Applying for funding from the NIHR research evaluation programmes

Transcription

1 Applying for funding from the NIHR research evaluation programmes Dr Sarah Puddicombe Assistant Director, NETSCC

2 Introduction Overview of NIHR NIHR Funding Programmes and remits Overview of application assessment process What makes a good application Tips for success

3 What is the NIHR? The National Institute for Health Research (NIHR) aims to improve the health and wealth of the nation through research Commissions and funds NHS, social care and public health research to develop the research evidence to support decision making by professionals, policy makers and patients. 1% of NHS budget ( 1 billion) funds NIHR the research arm of the NHS

4 The NIHR Health Research System

5 NIHR plays central role in the innovation pathway Interventions pharmaceuticals biologicals biotechnologies procedures therapies practices Health areas prevention detection diagnosis prognosis treatment care

6 What is applied research? Research with the capacity to improve patient and public outcomes and NHS services Multiple methodologies - not only trials Not Discovery science Work involving animals or animal tissue

7 Commissioned work stream Designed to meet the needs of decision makers, typically but not exclusively within NHS. Topics prioritised by expert panels and commissioning briefs advertised to address identified evidence need. Regular calls - up to three times year Single stage or two stage process dependant on programme and call. Primary research and evidence synthesis. NIHR Programmes: Efficacy and Mechanism Evaluation Health Technology Assessment Health Services and Delivery Research i4i Challenge Awards Public Health Research

8 Researcher-led work stream Calls for applications on research topics/questions directly proposed by researchers. Highlight notices/ themed calls in areas of specific need. Applications prioritised on NHS or other information need by advisory panels/boards. Dependant on programme and call: Regular calls - up to three times year Single stage or two stage process. Primary research and evidence synthesis. NIHR Programmes: Efficacy and Mechanism Evaluation Health Technology Assessment Health Services and Delivery Research i4i Product Development Awards Programme Development Grants Programme Grants for Applied Research Public Health Research Research for Patient Benefit

9 NIHR Themed calls NIHR themed calls are issued to meet an identified health challenge or government priority Calls issued once a year Cross NIHR initiative Different timings across programmes Previous calls have focused on: Obesity, Dementia, Surgery, Primary Care Interventions, Very Rare Diseases, Long term conditions in childhood, Multi morbidities in older people, Antimicrobial resistance Applications in all previous themed call areas continue to be welcomed by NIHR via researcher led calls Current calls -Prevention and treatment of obesity - Antimicrobial resistance

10 Which funding programme?

11 Which programme should I choose?

12 Which Programme? EME exploratory trials, efficacy, safety some effectiveness, phase 2b-3 studies on new interventions mainly devices, pharmaceuticals, plus mechanistic studies HTA - Systematic reviews, large multicentre pragmatic studies in NHS, mainly quantitative, phase 3-4 clinical and cost effectiveness compared to standard care HSDR - Models of delivery, patient experience, systems research, service organisation, social care and health, mainly qualitative, mixed methods, quantitative trials, research on implementation, knowledge mobilisation PHR - non-nhs based interventions to improve population health, natural experiments, trials in community settings, qualitative & quantitative, doesn t fund intervention, health related outcomes

13 Eligibility for Programmes England Wales Scotland Northern Ireland EME HSDR * HTA PHR * HSDR (researcher-led) workstream only. For commissioned calls coapplicants from Scotland can participate on eligible UK Chief Investigator bids

14 Which Programme? i4i - translational R&D of innovative medtech and devices to aid clinical adoption in NHS PGfAR Interrelated programme of studies with practical application to improve health care or delivery in NHS, qualitative, quantitative, health services research, public health research, behavioural research, economic evaluations, and modelling RfPB - regionally funded NHS research to leading to patient benefit locally or nationally, qualitative, quantitative research, feasibility studies Training Awards and Fellowships - doctoral, post doctoral and senior awards in England and Wales to suit different work arrangements, types of NHS staff and career paths and research training with clear potential to benefit patients

15 Eligibility for Programmes England Wales Scotland Northern Ireland PGfAR RfPB i4i * * # TCC Fellowships and Clinical Scientists *NHS England with collaborations from academic institutions; award goes to NHS organisation (or other provider of NHS services) # i4i Product Development Awards only check eligibility. Welsh organisations can be subcontracted on fee for service basis Applicants from Devolved Administrations are able to be coapplicants/collaborators where CI is in England based NHS or as applicable HEI

16 Programme Remits

17 Managed translational pathway INVENTION EVALUATION ADOPTION DIFFUSION MRC Efficacy Mechanism and Evaluation (EME) NIHR Invention for Innovation (i4i) DH/Wellcome Trust Health Innovation Challenge Fund (HICF) Research Schools Research for Patient Benefit (RfPB) Public Health Research (PHR) Programme Grants for Applied Research (PGfAR) Health Services and Delivery Research (HS&DR) Health Technology Assessment (HTA) Systematic Review Programme (SR) Technology Assessment Reviews (TARs) NIHR Research Training Awards*

18 Efficacy & Mechanism Evaluation Programme (EME) Jointly funded by MRC and NIHR & administered by NIHR Bridges the gap between preclinical studies and evidence of clinical efficacy Clinical trials and evaluative studies in defined patient groups which: Definitively evaluate clinical efficacy and safety of health care interventions (where proof of concept in humans has already been achieved) are hypothesis driven and significantly increase understanding of disease or treatment mechanisms explore new scientific or clinical principles include the development or testing of new methodologies include validated surrogate markers as indicators of patient outcome Researcher-led and Commissioned (3 each /year) - two stage process Primary research, no limit on funding or duration Programme Director Professor Tom Walley

19 EME project examples EME 12/10/104 : A randomized controlled trial of a duodenal sleeve bypass device (Endobarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes. Professor Julian Teare, Imperial College London 1,613, (45 months) StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): A randomised, double-masked, shamcontrolled, clinical trial comparing low-voltage X-ray irradiation with as needed ranibizumab, to as needed ranibizumab monotherapy Mr Timothy Jackson, King s College London 2.2M (95 months) Selection of sperm for Assisted Reproductive Treatment by prior hyaluronic acid binding: increasing live birth outcomes and reducing miscarriage rates (Hyaluronic Acid Binding Sperm Selection; HABSelect). Professor David Miller, University of Leeds 1.4M (42 months)

20 Health Technology Assessment Programme (HTA) Research evidence on the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS Health technology is any intervention used to promote health, prevent and treat disease and improve rehabilitation and long term care, including drugs, devices, procedures, settings of care and screening Researcher-led and commissioned calls (3 calls/year) No limit on funding or duration Primary research and evidence synthesis Programme Director Professor Hywel Williams

21 Typical HTA study o Multidisciplinary and multi-centre o Effectiveness and cost-effectiveness (usually estimate /QALY) o Pragmatic and externally valid o Median number of patients = 700 (Range of 15 to 75,000 across current projects) o Average duration ~4 years and ~1.5 m o Protocols available on web site Types of studies funded: o randomised controlled trials and non-randomised trials o stand-alone pilot and feasibility studies (where there is evidence they will lead to a full trial) or embedded pilot/ feasibility o cohort studies (retrospective or prospective) o adaptive and efficient study designs, methodological studies o evidence synthesis and modelling studies

22 HTA Project Examples Add-Aspirin Trial: A phase III double-blind placebo-controlled randomized trial assessing the addition of aspirin after standard primary therapy in early stage common solid tumours Professor Ruth Langley, University College London 3.1M (144 months) HTA 09/127/53: Gastric Bypass, adjustable gastric Banding or Sleeve gastrectomy surgery to treat severe and complex obesity: a multi-centre randomised controlled trial (The By-Band-Sleeve Study) Professor Jane Blazeby, University of Bristol, 3,939,934 (119 months) Early detection of neovascular age-related macular degeneration Professor Usha Chakravarthy, Queen's University Belfast 2.2M (63 months)

23 Health Services & Delivery Research Programme (HSDR) Funds research to produce evidence on the quality, accessibility and organisation of health services, including evaluations of how the NHS might improve delivery of services. Ambitious evaluative research to improve health services on topics of importance to NHS and leading to changes in NHS practice and impacting large numbers of patients Audience for research is the public, service users, clinicians and managers Researcher-led and Commissioned ( 3 calls each a year) Funds both primary research and evidence synthesis No limit on funding or duration Programme Director Professor Jo Ryecroft- Malone

24 HS&DR Project examples Effects of a demand led knowledge translation service on the uptake and use of research evidence by NHS commissioners compared with lower intensity untargeted alternatives Professor Paul Wilson, University of York 0.6M (27 months) Support matters: use of assistant staff in the delivery of primary and community nursing services in England Professor Karen Spilsbury, University of York 0.3M (27 months) HS&DR 12/500/12: Cost-effectiveness of different levels of uptake of bariatric surgery in a large population. Cohort study and Markov model Professor Martin Gulliford, King's College London, 352,603 (23 months)

25 Public Health Research Programme (PHR) Funds research that evaluates public health interventions, specifically to provide new knowledge on the benefits, costs, acceptability and wider impacts of non-nhs interventions intended to improve the health of the public and reduce inequalities in health Scope is multi-disciplinary and broad, covering a range of interventions that improve public health e.g. evidence for education, local decisions, environmental health Primary outcome must be health related Researcher-led & commissioned (3 calls each /year) Primary research and evidence synthesis No limit on funding or duration Programme Director Professor Martin White

26 PHR Project Examples Football Fans in Training (FFIT): an RCT of a gender-sensitive weight loss and healthy living programme delivered to men aged by Scottish Premier League football clubs Professor Sally Wyke, University of Glasgow What is the effect of reduced street lighting on crime and road traffic accidents at night? A mixed methods study Dr Philip Edwards, London School of Hygiene & Tropical Medicine Reducing binge drinking among disadvantaged men through a brief intervention delivered by mobile phone Professor Iain K Crombie, University of Dundee

27 Invention for Innovation (i4i) Advances the translation and adoption of innovative healthcare technologies into the clinic Funds collaborative R&D projects involving academics, clinicians or companies working in the medtech sector in England and Wales De-risk projects for follow-on investment Two calls year (2 stage): i4i Product Development Awards (researcher led) funds projects that have strong potential for commercialisation and NHS adoption i4i Challenge Awards (commissioned) are theme based and funds projects that bridge the gap between development of new medical technologies and their adoption into clinical pathways. No funding limit, max duration 3 years; Programme Director: Professor Martin Hunt Further information: or i4i.programme@nihr-ccf.org.uk

28 Research for Patient Benefit Researcher-led funding programme for small grants. Maximum award 350,000 for up to 3 years (max 250,000 for feasibility studies and 150,000 for more upstream proposals). Awards made to NHS bodies and other providers of NHS services in England with subcontracts to academic partners. Eight Regional Advisory Panels. Three funding competitions per year. Two stage application process 22% success rate for peer reviewed applications Programme Director: Professor David Armstrong Information: rfpb@nihr.ac.uk

29 Programme Grants for Applied Research Response mode funding for programmes of research. No limit on funding amount or duration*. Awards made to NHS organisations in England with subcontracts to academic partners. Three funding rounds per year. Programme Director Professor Paul Little *Amount and period of funding depends on nature of proposed work. Funding above 2.5 million and duration more than six years will be unusual. Funding data accurate as of Nov 15 Further information: or

30 Programme Development Grants Sub-Programme of PGfAR Programme. Response mode funding for small pieces of research needed to underpin future research programme. Individual awards for 20, ,000 over a period of 6 18 months. Awards made to NHS organisations in England with subcontracts to academic partners. Three funding rounds per year. Funding data accurate as of Nov 15 Further information: or programme.grants@nihr-ccf.org.uk

31 For further information about the programmes and latest funding opportunities, please visit:

32 NIHR programmes application and assessment process

33 Maximising the potential impact of health research funding

34 Overview of an application process Funding Call Outline application Competitiveness & remit Check Advisory panel/ Board assessment Feedback and invite full proposal Full application External Review Advisory panel/ Board assessment Recommendations to DH Two stage process (outline/eoi & Full) Advisory Panels consider importance/need (variations across NIHR) Panels/Boards consider scientific quality, feasibility, host, team and value for money External peer and public review (optional at outline & compulsory at full) Submission to decision: ~ 3.5 months Evidence Synthesis (straight to full - one stage) ~7.5 months Primary or ES ( EoI/outline and full - two stage)

35 Board membership Approximately 20 members All experts in their respective fields Eclectic mix Clinical, statistical, health economics, quantitative, qualitative, organisational expertise, trialist Two public or patient members Expertise relevant to programme remit e.g. Service managers and NHS commissioners for HS&DR board

36 Expert Review Outline proposals option for 1 clinical /professional review Full Primary research proposals - 5 to 6 reviewers Reviews generally comprise: 2-3 Clinical or professional experts 2 methodologists (statistical/health economics/ trialist) 1 public or patient review Additional methodological or International review on higher cost studies > 2m Applicants invited to respond to reviewer comments Reviews and applicants responses shared with board

37 What happens at the board All members receive outlines and full application papers Applications Reviewers comments Applicants response to referees comments ~ 40 outlines & 20+ full proposals are considered per Funding Board meeting Three Designated Board Members per application (one lead DBM + 2 supporting DBMs of any discipline) Specific comments on Public and patient involvement Outcome and board feedback

38 Applying for research funding - Tips for success Know your target What are the aims of the funding scheme? Am I eligible for support? How will the application be assessed? Who will assess the application? When will the application be assessed? What is the scale of a typical award? Who has received previous awards? What research is already in the portfolio?

39 Commissioned vs Researcher-led? Commissioned Researcher-led Importance for research identified by programme Read the commissioning brief Check the supporting specification document and remit info Ensure your project fits tailor if needed Check the remit of the programme Search for funded projects (website) for examples info on costs, duration, methodology, team etc Justify importance of your research Contact the programmes in case of query in summary for remit advice

40 Choose the right research question Has it already been answered? Has the funding stream funded similar research? Is it important, does it matter to patients? Is it timely and will it make a difference to health? Will doctors and allied health professionals care enough to want to participate? Can it be implemented in the NHS?

41 Use available support in designing the right project Our Research Design Service (RDS) provides design and methodological support to health and social care researchers across England INVOLVE is our national advisory group supporting active public involvement in NHS, public health and social care research Our Clinical Trials Units (CTUs) provide specialist expert statistical, epidemiological and other advice and coordination to undertake successful clinical trials Clinical Research Networks (CRN) across the UK to support development and delivery of clinical studies

42 Choose the right research method and describe it clearly and fully Is an RCT appropriate? Primary outcome Control group Sample size/ power Recruitment and retention Avoiding bias If using a non-rct design is it robust? Would a mixed methods or qualitative study be appropriate? Is it worth investigating cost-effectiveness? Use check lists: CONSORT, SPIRIT, EQUATOR

43 Pick your team carefully Seniority of Chief Investigator Consider involving a CTU/ RDS/ networks Comment on track record and experience Make sure enough statistical support is in place Include team members with expertise in specific methodologies (e.g. health economics, qualitative research) and experience (trials, commissioning) Demonstrated PPI at all stages Avoid too many chiefs!

44 Make sure the proposal is feasible Design Context Timing Provide evidence of feasibility If unclear consider a feasibility study (with pre-defined feasibility criteria) Recruitment rate: Study sites, eligible patients, patient consents, follow-up, adequate retention of participants, expectations of service providers/patients consider contingency arrangements Leave enough time for study set up, including ethics and research governance approvals and include the costs for this phase

45 Include public and patients (and pay them) Public and Patient involvement (PPI) matters to the NIHR - consider it carefully and justify your decisions Were patients and public were actively involved in : Identifying the research topic or prioritising the research questions? If not why not? Preparing the application? If yes, give details. How PPI informed and/or influenced the development of the application and how patients and the public have been involved. If no, please explain why patient and public involvement was not thought necessary. Please indicate the ways in which patients and the public will be actively involved in the proposed research. If active involvement is planned, please give more details, including how it will benefit the research, the reasons for taking this approach and arrangements for training and support. If there are no plans for active involvement, please explain why it is not thought necessary

46 Produce a carefully costed proposal Sorting out the budget takes time! Is cost to address the health issue justified? Does the topic account for costs requested and provide value for money - be realistic in costing Cost at plausible % FTE rates Full applications are scrutinised by NIHR accountants who will check and challenge For many funding streams total costs should be identified at the outline stage with limited wiggle room at the full stage Account appropriately for research costs, NHS treatment costs and NHS support costs

47 Think about target audience/ presentation Simple English for mixed audience Clinical, methodologists, reviewer, panel /board Patient and public Tell the story well for the non-expert Clear plain English summary Follow the writing guides/ Newspaper style Visible headings (e.g. sample size, outcomes, technologies) Create white space use paragraphs Flow diagrams PROOF-READ SUBMISSIONS CAREFULLY!

48 Consider pathways to impact Think about who the main stakeholders are for your research and how learning can be shared rapidly and effectively with them Commissioners Providers Health care professionals Patients and public Consider working with stakeholders to develop your dissemination plan Be creative and plan to target all audiences (not just publications - movie, website, social media )

49 Tips for success Read the detailed brief, call guidance notes & FAQs Check application fits within the programme remit & Check the existing portfolio of research and UKCRN portfolio: Logical proposal addressing clear evidence need Research findings will be timely and will matter to decision makers and the public Demonstrated PPI and good quality plain language summary Don t leave it to the last minute

50 Avoid common pitfalls Address any changes requested by the Board at outline phase Constructively address (or refute) referees comments

51 Get help Use web resources Guidance notes, FAQs, remits Podcasts and resources for applicants Contact us we re friendly and helpful

52 Get involved Suggest future commissioned research topics & notification when your research topic is advertised Become a reviewer Trainees reviewer development scheme Professional and public contributors welcome: Apply for Panel member/board member roles - advertised regularly on our website Join our mailing lists for programme and funding bulletins ; ;

53 Any Questions?