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Managing evaluation research on behalf of the National Institute for Health Research RDS and CTU Training and Information Event 8 November 2011.

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Presentation on theme: "Managing evaluation research on behalf of the National Institute for Health Research RDS and CTU Training and Information Event 8 November 2011."— Presentation transcript:

1 Managing evaluation research on behalf of the National Institute for Health Research RDS and CTU Training and Information Event 8 November 2011

2 Managing evaluation research on behalf of the National Institute for Health Research NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) & NETS Programmes – An overview Dr Martin Ashton-Key RDS & CTU Information Event 8 November 2011

3 Outline ►To provide RDS and CTU staff with an overview of the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) & the NETS programmes ►To highlight the key functions and interactions ►To then hand over to the individual NETS programmes

4 Background – Research pathway

5 The NIHR Health Research System Research Research Projects & Programmes Research Governance Systems Research Information Systems Patients & Public Universities Investigators & Senior Investigators Associates Trainees Research Schools NHS Trusts Clinical Research Networks Clinical Research Facilities, Centres & Units Infrastructure Systems Faculty

6 Background: NETSCC ►Health related research now funded through 2 main routes: NIHR and MRC ►NIHR Evaluation, Trials and Studies Coordinating Centre - (NETSCC) ►Funded by the National Institute for Health Research (NIHR)

7 Managing evaluation research programmes on behalf of NIHR ►NIHR Evaluation, Trials and Studies (NETS) programmes ►Efficacy and Mechanism Evaluation (EME) programme ►NIHR Health Services Research (HSR) programme ►NIHR Health Technology Assessment (HTA) programme ►NIHR Public Health Research (PHR) programme ►NIHR Service Delivery and Organisation (SDO) programme

8 Managing evaluation research programmes on behalf of NIHR ►NIHR Evaluation, Trials and Studies (NETS) programmes ►Efficacy and Mechanism Evaluation (EME) programme ►NIHR Health Services and Delivery Research (HS&DR) programme ►NIHR Health Technology Assessment (HTA) programme ►NIHR Public Health Research (PHR) programme

9 NIHR Evaluation, Trials and Studies (NETS) programmes- from 2012 NETSCC Public Health Research Established: 2008 Health Technology Assessment Established: 1993 Health Services and Delivery Research Will be established from 2012 Efficacy and Mechanism Evaluation Funded by the MRC and NIHR Managed by NIHR Established: 2008

10 Research themes Research theme Technology evaluation Health services & organisation Public health EME  HS&DR  HTA  PHR 

11 Research for public health at NETSCC ►The NETS programmes play a vital role in producing high quality, relevant work that aims to add significant value to the implementation of public health practice ►The NETS funded research provides valuable information to public health professionals, researchers and government to ensure that public health is at the centre of improving the nation’s health ►NETSCC provides a coordinated, joined-up approach to public health research across a wide research remit ►NETSCC is alert to emerging national research priorities in public health and responds by giving them appropriate emphasis within the NETS programmes, e.g. obesity and dementia

12 Needs-led and science-added approach for NETS programmes ►We are: Needs-led because we assess what the important questions to the NHS and other information consumers are, and in what priority they should be answered ►We are: Science-added because we ask does the proposal meet the scientific quality we insist on, and how can we support the delivery of quality ►We provide: Value for money because assessment of need and scientific support maximises the relevance and benefits achievable within a funding stream

13 Funding workstreams ►Commissioned workstream ►Starts with the information needs of decision makers typically, but not exclusively, within the NHS but also Public Health outside the NHS ►Topics are refined and prioritised by people with expertise in the field, and commissioning briefs are advertised ►Applications are then assessed for compliance with the commissioning brief, scientific quality, feasibility and value for money ►Researcher-led workstream ►Open calls for researchers to apply for funding for their own topics and questions ►Applications are prioritised in terms of NHS or other information need in a process similar to that in the commissioned workstreams ►Applications are then assessed for scientific quality, feasibility and value for money

14 Feasibility studies ►Other definitions are used elsewhere but we apply the following in order to help us communicate with applicants ►Feasibility study ►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

15 Pilot studies ►Pilot study ►Pilot studies are a small scale versions of the main study that run to test whether the components of the main study can all work together ►Focused on the processes 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 data from the pilot phase may contribute to the final analysis ►An external pilot is one where the data may be analysed but set aside in respect of the substantive study

16 Full and appropriate funding ►We provide: ►Full and appropriate funding because we place no upper limit on the amount of funding granted for a project ►If the question is important enough and the science requires it, we will fund it ►University based projects: we fund up to 80% of the Full Economic Cost (FEC) ►NHS Trust based projects: we fund 100% of the direct costs ►Other organisations are also welcome to apply

17 Eligibility ►EME researcher-led workstream uses research council eligibility criteria and is open to applicants from the whole of the UK. The EME commissioned workstream requires all applications to be in the form of a significant collaboration between at least two of the following partners; industry, academia, and the NHS. ►HTA, PHR and HS&DR [HSR, SDO] have broader eligibility criteria and will consider applications from any applicants who consider that they are able to conduct the study.

18 NIHR Clinical Trials Unit Support Funding ►Launched 2008 ►Recognises the importance and crucial role played by CTUs in designing and delivering quality NETS research applications and projects ►Provides ‘priming’ funding to support CTUs on a 3 year rolling contract and provide stability to units (allowing expansion and retention of skilled staff)

19 NIHR Clinical Trials Unit Support Funding ►Intended to result in an increased number of high quality research applications submitted to NETS programmes ►22 CTUs in England supported to date on rolling contract basis ►Three funding bands:£150, 200, 250k per annum ►All payments are made directly to CTUs ►Funding adjusted according to successful grant applications

20 NIHR Reviews Infrastructure ►NETSCC manages the contracts for Reviews Infrastructure on behalf of the NIHR ►Systematic Reviews provide decision-makers with the best possible information about the effects of tests, treatments and other interventions used in health and social care ►There are four entities which comprise the NIHR Reviews Infrastructure: ►UK Cochrane Centre and Cochrane Review Groups ►Centres for Reviews and Dissemination ►Diagnostics Evaluation Unit ►The Unit for Improved Monitoring in Long Term Disease ►For information on NETSCC’s role within the Reviews Infrastructure, please visit:

21 Public involvement in NETS programmes ►Patients, service users and members of the public are involved in: ►Identifying research topics ►Prioritising topics to be developed further ►Reviewing research briefs/vignettes as they are compiled ►Prioritising research briefs/vignettes to be advertised as calls ►Reviewing proposals submitted by researchers

22 Strategic development of PPI in NETS programmes ►Closer working with patient/service user organisations on topic identification ►Open recruitment of wider group of public contributors to prioritisation and commissioning ►Panels & boards require clear evidence of commitment to PPI in design and conduct of research ►Wider dissemination of ‘plain English’ findings to interested communities ►Reference group of public contributors to advise on strategic development of PPI

23 Summary ►NETSCC has responsibility for coordinating all the NETS programmes ►NETSCC has additional functions including Reviews Infrastructure / CTU funding ►NETSCC is keen to work with the RDS and CTUs to ensure applicants have best opportunity for success ►NETSCC is here to help

24 Further information Visit:

25 Thank you

26 Managing evaluation research on behalf of the National Institute for Health Research Efficacy and Mechanism Evaluation (EME) programme Lisa Douet 8 November 2011

27 Outline ►Background ►Remit ►Assessment process ►Board members ►Examples of funded research ►Summary

28 Managed Translational Pathway

29 Translating science into better health ►MRC: can it work? ►EME: does it work? ►HTA: is it worth it? ►The EME programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland, NISCHR in Wales and the HSC R&D, Public Health Agency in Northern Ireland ►It is applicable to all parts of the UK

30 Background ►The EME programme funds research through two main workstreams: ►Researcher led workstream - funds research questions proposed directly by researchers ►Commissioned workstream - advertises calls for research proposals that address specific research areas ►Additionally the EME programme may commission research through: ►Themed calls – advertises for research proposals that address themed areas. These are one-off calls for research in areas where a particular need has been identified and are advertised on ad-hoc basis

31 Translational pull through Translational pull through Researcher-led Types of Research Primary Research; Clinical efficacy of interventions Primary Research; Clinical efficacy of interventions Who defines the question? Researcher EME programme Frequency Per year Continuous with 3 submission deadlines As required Commissioned Primary Research; Clinical efficacy of interventions EME programme 3 calls per year

32 The EME programme remit ►The EME programme is broadly aimed at supporting 'science driven' studies with an expectation of substantial health gain and aims to support excellent clinical science with an ultimate view to improving health or patient care ►The remit includes evaluations of new treatments, including therapeutics (small molecule and biologic), psychological interventions, public health, diagnostics and medical devices. Treatments or interventions intended to prevent disease are also included

33 EME will support clinical trials and evaluative studies in patients that: ►Provide definitive evidence of efficacy of healthcare interventions, including size of effect, safety and effectiveness ►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 ►Laboratory studies as part of the main study, if relevant to the EME remit ►The EME programme will not support animal studies

34 Researcher-led workstream ►The EME researcher led workstream will not fund: ►Proof of concept in humans must be established prior to applying to the EME commissioned workstream ►confirmatory studies or trials of incremental modifications and refinements to existing medical interventions

35 Mechanisms of working: researcher-led workstream ►Standard mode (two stage application) ►On going call with 3 closing dates a year ►All in remit and competitive preliminary applications are peer reviewed before Board assessment ►If successful full application to the next Board. ►Preliminary application submission deadline to funding decision around 8 months ►Fast track (single stage application) ►Normally expected to use the standard funding mode ►Single stage application process reducing time to funding decision by about 3 months ►Only used where reducing the timescale will provide significant benefit, or exploitation of a narrow window of opportunity ►All cases for an application are discussed with the EME team to ensure that there is a need for the reduced timescale

36 Mechanisms of working: commissioned workstream ►Applications to the EME commissioned work stream should be in the form of a significant collaboration. All applications should include significant contributions from at least two of the following partners; industry, academia, and the NHS ►EME commissioned aims to fund large staged projects of work which have clear go/no go milestones ►Early stages may include: proof of concept studies, pilot studies, feasibility studies and late stage development of the intervention. However, the majority of the study should be an efficacy study

37 Mechanisms of working: commissioned workstream ► Specific topics advertised three times a year ►Research areas are identified and prioritised by the Prioritisation Group ►Prioritised research topics are advertised and request submission of preliminary applications ►All in remit and competitive preliminary applications received will be prioritised prior to peer review before Board assessment ►If successful at preliminary stage a full application is submitted to the next Board ►A funding decision takes around eight months from the close of the commissioning brief

38 The EME Board ►Chaired by Professor Rajesh Thakker ►26 members - Board membership comprises senior, experienced clinicians and methodologists (including clinical trial specialists and statisticians) who are all active researchers in their field ►Meets three times per year ►Supported by the NETSCC, EME scientific secretariat (directed by Professor Ian Cree)

39 Funded studies ►Since April 2008 the EME Board has funded 31 researcher led studies ►The funding projects have received ranges from £124, 000 to £1.79 million and the duration ranges from 18 to 66 months ►The first funding decisions for the commissioned workstream will be in Jan It is anticipated that the majority of EME commissioned studies will cost between £500,000 to £2 million ►However, for both workstreams there is no upper limit to funding as long as the funding requested is justified in the application

40 Examples of funded research Aims to show that DNA vaccination, directed against the tumour protein, WT1, can control the progression of the disease Professor Christian Ottensmeier (University of Southampton) 48 months from 1st September 2010 (£973,304) A novel anti-Wilms- Tumour-1 (WT1) vaccination strategy in haematological malignancy using DNA fusion vaccines delivered with electroporation

41 Summary ►The key focus of all EME studies is to establish clinical efficacy of an intervention: ►For the researcher-led workstream proof of concept in humans must be established prior to application ►For the commissioned workstream, applications are expected to be in the form of large multi-stage projects for which the majority of the funding is for the efficacy study but may include earlier work ►The researcher-led is an on-going call with three close dates a year ►The commissioned workstream has three calls a year.

42 Thank you

43 Managing evaluation research on behalf of the National Institute for Health Research NIHR Health Technology Assessment (HTA) programme Andrew Cook 8 November 2011

44 Outline ►Background and Remit ►Boards and Panels ►The Workstreams ►Portfolio ►Current and Future Calls

45 NIHR Health Technology Assessment programme ►Purpose and Remit To deliver information about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS ►The HTA programme includes The programme includes all interventions used to promote health, prevent or treat disease, improve rehabilitation or long-term care including drugs, devices, procedures, settings of care and screening

46 Panel and Boards: Stages of Assessment

47 Prioritisation Panels ►Six areas ►Pharmaceuticals ►Diagnostics and Screening ►Interventional Procedures ►External Devices and Physical Therapies ►Psychological and Community Therapies ►Disease Prevention ►Membership ►Between 12 and 20 members ►Clinicians, Commissioners, Patients and Public

48 Prioritisation Group ►Membership ►The Programme Director ►Chair of the Commissioning Board (Deputy Programme Director) ►Chair of the Clinical Evaluations and Trials Board ►Chairs of the Prioritisation Panels

49 Commissioning Board and CET Board ►Membership ►Clinical Academics ►Methodologists

50 The HTA programme offers 3 funding workstreams: Types of Research Specific technology assessment Primary research Feasibility & pilot Evidence synthesis Who defines the question? NICE Researcher Frequency Per year Primary research Evidence synthesis Theme from HTA programme Question from researcher Continuous with 4 closing dates Researcher Led Primary research Feasibility & pilot Evidence synthesis HTA programme4 calls Clinical evaluation Clinical evaluation Themed Calls 1 call NICE Guidance Commissioned Direct referral to On-contract teams

51 Commissioned Workstream ►Commissioning briefs designed by Prioritisation Panels and approved by Prioritisation Group ►May advertise Primary Research or Evidence Synthesis ►Proposals go directly to Commissioning Board ►i.e. proposals responding to a commissioning brief are assumed to have passed the NHS importance threshold ►Currently, 4 calls per year of 5 to 25 priority areas

52 Researcher-led Workstream (Clinical Evaluations and Trials) ►Applicants propose what they consider to be important projects, within the overall remit of the programme ►May be Primary Research (including pilot and feasibility work ) or Evidence Synthesis ►Proposals are assessed by the relevant Prioritisation Panel and PG for importance to the NHS ►Those which pass the NHS importance threshold are considered by the CET board for scientific quality ►Continuous application, currently 4 cut off dates per year

53 Researcher-led Workstream (Themed Calls) ►Usually one themed call each year, sometimes in conjunction with other NIHR programmes ►2011 – Dementia, Pandemic Influenza ►2010 – Obesity ►Applicants propose what they consider to be important projects, within the overall remit of the themed call ►May be Primary Research or Evidence Synthesis ►Proposals are assessed by a themed called board for NHS importance and scientific quality

54 A typical HTA randomised controlled trial ►Multidisciplinary and multi-centre ►Effectiveness and cost-effectiveness ►Pragmatic and externally valid ►Median number of patients = 700 (Range of 15 to 100,000 across current projects) ►Average duration 4-5 years

55 Outputs ►All projects publish in our MEDLINE indexed journal ►Papers in key journals over the past 5 years ►BMJ 59 ►New England Journal of Medicine 5 ►The Lancet 29 ►Annals of Internal Medicine 3 ►British Journal of Cancer 13

56 Portfolio ►173 trials underway ►33 trials with funding approved in start up, getting permissions etc. (As of 31 October 2011)

57 Examples of HTA funded primary research

58 Current Calls – Commissioned Mode ►Quitting Smoking in Pregnancy ►Prevention of irritant hand dermatitis ►Immunisation of looked after children ►Surveillance programmes for people with inflamatory bowel disease ►Cystatin C for assessment of renal function ►Nutrition for maintence of remission in Crohn’s disease ►Radiofrequency renal sympathectomy for treatment of resistant essential hypertension ►Surgical treatments for urinary incontinence after prostate surgery ►Ablation for suspected renal tumours ►Palliative care for lung cancer ►Interventions for parents of excessively crying infants ►Interventions for psychosexual dysfunction after gynaecological malignancy ►Treatment of fatigue in inflammatory arthritis ►Timing of intravenous fluids after trauma ►Long acting contraception for secondary prevention of endometriosis

59 Current Calls – Rapid Trials ►The HTA programme is inviting expressions of interest to undertake randomised controlled trials in any speciality, disease area or clinical setting that will generate evidence in the short to medium term to inform clinical decision making in the NHS. ►The deadline for submissions is 1pm on Friday 18 November ►Funding decisions are expected by mid 2012 ►Funded trials must commence within 9 months of funding decision

60 Future Calls – Researcher Led ►Future Cut Off Dates for CET Workstream ►30 January 2012 (Evidence Synthesis particularly welcomed, as full proposals) ►Early June 2012 ►Early October 2012

61 Summary ►The HTA programme is interested in studies with any robust design to answer evaluation questions within its remit ►We’ll fund feasibility work, pilot studies and definitive trials – or all three within a single contract – depending on the most appropriate way to answer an important question ►The programme pays as much attention to the NHS’s need for a project’s research question as to the robustness of the science – if a question doesn’t meet a threshold for NHS need no one will ever consider the project’s scientific merit

62 Thank you

63 Managing evaluation research on behalf of the National Institute for Health Research NIHR Public Health Research (PHR) programme Matt Westmore 8 November 2011

64 Outline ►Background ►Remit ►Assessment process ►Programme advisory and funding board members ►Current calls ►Funded projects

65 Background ►Purpose and Remit The PHR programme evaluates non-NHS public health interventions for benefits, costs, acceptability and wider impact and to reduce inequalities in health ►History The PHR programme was launched in Autumn ►Unique characteristics Non-health care settings Intervention evaluation Wide range of methodologies supported

66 PHR programme funding opportunities ►Average cost and duration is £700k over 3 years (range £200k - £1.4m) ►The PHR Programme offers 2 funding workstreams: Commissioned and Researcher-led ►Each takes about 7 months from call close to a fund decision Commissioned Researcher-led Types of Research Non-NHS Primary research Evidence synthesis Non-NHS Primary research Evidence synthesis Who defines the question? Researcher PHR programme Frequency Per year Continuous with 3 closing dates As required (10-12 per year)

67 Funding streams ►Researcher-led workstream (2-stage application) ►Occasional highlight notices ►Outline proposals are assessed by the Programme Advisory Board for public health importance ►Outline proposals are shortlisted, and full proposals are assessed by the Research Funding Board for scientific quality, feasibility and value for money. ►Commissioned mode (two stage application) ►Commissioning briefs developed and prioritised by Programme Advisory Board ►Outline proposals are shortlisted, and full proposals are assessed by the Research Funding board for scientific quality, feasibility and value for money.

68 Funding streams ►Fast track (single stage application) ►Normally expected to use the standard funding mode but exceptionally researchers can request to use the fast track scheme. ►Usual justification is timeliness of the research (e.g. natural experiment, follow-on study, need of research users) ►Contact NETSCC to discuss

69 Assessment boards ►Programme advisory board (public health need) ►Chair: Professor Catherine Law (NIHR PHR programme director) ►Members are in their personal capacity but include: ►Chief Executives – 3rd sector ►Directors of public health ►Director of Association of Public Health Observatories ►Chief Executive, UK Public Health Association ►Directors from local authorities ►Currently recruiting public contributors

70 Assessment boards ►Research funding board (scientific quality, feasibility and value for money) ►Chair: Professor Catherine Law (NIHR PHR programme director) ►Members include: ►Professors in health economics, epidemiology and statistics ►Professors in public health, health policy and promotion

71 Current and future calls ►Commissioned work stream ►Next calls close (approx) April 2012 ►Outlines proposals: Research Funding Board June 2012 ►Full Proposals: Research Funding Board October 2012 ►Researcher-led ►Call close 21 November 2011 ►Outline proposals: Programme Advisory Board January 2012 ►Outline proposals: Research Funding Board February 2012 ►Full Proposals: Research Funding Board June 2012 ►Call close April 2012 ►Outline proposals: Programme Advisory Board May 2012 ►Outline proposals: Research Funding Board June 2012 ►Full Proposals: Research Funding Board October 2012

72 Examples of funded public health research ►PHR has funded 23 projects across a broad range of topics and methodologies ►We have funded quantitative, qualitative and mixed methods studies; evidence synthesis, natural experiments, and randomised controlled trials.

73 Examples of funded public health research

74 Summary ►All NETS programmes fund public health research ►The NIHR Public Health Research programme focuses on interventions commissioned and/or delivered outside of health services ►PHR evaluates public health interventions, providing 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 ►It funds through commissioned calls (10-12 per year) on specific or broad topics; and in researcher-led mode (3 calls per year)

75 Thank you

76 Managing evaluation research on behalf of the National Institute for Health Research NIHR Health Services & Delivery Research (HS&DR) programme Tara Lamont 8 November 2011

77 Outline ►Background, remit and review process ►Recent calls ►Funded projects ►Funding profile of projects ►Summary

78 Background ►Purpose and Remit To produce rigorous and relevant evidence on the quality, access and organisation of health services. ►History This is a new programme and will be launched in January The HSDR programme builds on the strengths and contributions of two existing programmes – Service Delivery and Organisation (SDO) and Health Services Research (HSR) research programmes.

79 ►The HS&DR programme will have two workstreams: ►A mainly commissioned workstream focusing on evaluating models of service delivery and interventions which have the potential to improve service effectiveness, efficiency and productivity ►A mainly researcher-led workstream focusing on research into the quality, appropriateness, effectiveness, equity and patient experience of health services

80 Researcher-led Types of Research Primary research Evidence synthesis Who defines the question? Researcher Frequency Per year 3 calls per year Primary research Evidence synthesis HS&DR programme 3 calls per year (6+ topics) Commissioned

81 Expert review ► Panel ►Includes senior managers, clinical leaders, patients and researchers ►Assess outline proposals in commissioned workstream against service need and relevance ►Commissioning Boards ►Includes range of health service researchers and some service/clinical/patient input ►Assess full proposals against service need but also scientific rigour, durability, gaps in existing knowledge and value for money

82 Recent calls (commissioned) ►Integrating health and social care for older people and adults ►Primary care and community health services ►Research on knowledge mobilisation ►Patient safety ►Unplanned hospital admissions ►Financial management ►Dementia services ►Management of planned (elective) activity ►Interface between care homes and the NHS

83 Examples of funded research

84 Examples of funded projects (researcher-led)

85 Funding profile of projects ►336 projects funded to date ►Around three quarters primary research – mainly mixed methods, including case studies ►Average cost of project c £260k ►Average duration c 24 months

86 HS&DR programme would like to fund: ►Ambitious, large-scale studies of national importance ►May include multi-centre intervention studies to test and evaluate promising innovations in healthcare ►Range of studies – from evidence syntheses (around £100k) to primary research which may include ambitious studies of £2m+

87 Summary ►New NIHR HS&DR programme, focused on quality, access and organisation of health services ►Builds on strengths of current HSR and SDO programmes ►Researcher-led and commissioned streams – around 6 new topics a year in commissioned stream ►Encourage a range of research, from evidence reviews to ambitious primary care research on key service questions

88 Thank you

89 Managing evaluation research on behalf of the National Institute for Health Research NETS Programme Funding: Tips for applicants Dr Martin Ashton-Key RDS & CTU Information Event 8 November 2011

90 Researcher led vs commissioned ►Some specific points related to researcher led proposals ►Generic issues that are relevant to applications through both researcher led and commissioned routes

91 ‘Is the research question in remit?’ ►Is the research question within the remit of the specific NETS programme being applied to ►Talk to the programmes concerned or consult the NETSCC web pages: for advice

92 ‘Is the question important?’ ►The need for the research ►How much will patients, the NHS or the population (PHR) benefit from the proposed research ►Has the research question been explained clearly and the importance of topic made (e.g. burden of disease, impact on service / population, gaps in the knowledge identified and how this research will address these gaps)

93 ‘Is the research feasible?’ ►Design complexity ►Recruitment rate ►Centres ►Eligible patients ►Patient consents ►Patient follow-up ►Expectations of service providers / patients ►Experience, track record ►Sustainability, e.g. maintaining equipoise, burn-out, etc

94 ‘The science’ ►Sample size ►Effect size ►Outcomes ►Must be appropriate for programme applied to e.g. HTA patient centred, PHR population centred ►Composite measures (e.g. QALYs) or surrogates depending on programmes ►Useful to look at completed or on-going research on the programme websites

95 ‘The science’ ►Stage of development of technologies ►Especially for complex interventions ►Some programmes support developmental or exploratory studies where there is a clear path to the evaluation ►Comparators ►Best alternative, treatment as usual, placebos

96 ‘Infrastructure and support’ ►Research team – appropriately multi-disciplinary and sufficiently experienced ►Involvement with an RDS / CTU from an appropriate stage in the research development ►Involvement with appropriate research networks

97 ‘Costings’ ►Is the research realistically costed and does it offer value-for-money? ►Is the cost to address the disease / health issue in question justified, and does the topic clearly account for the cost requested?

98 ‘Presentation’ ►English for mixed audience ►Clinical, methodologists, patient and public ►Tell the story well for the non - expert ►Plain English summary ►Follow the writing guides here, not just in the publication. ►Visible headings ►(e.g. sample size, outcomes, technologies) ►White space – there should be some (use paragraphs) ►Flow diagrams ►PROOF-READ SUBMISSIONS CAREFULLY!

99 ‘Feedback from funding boards’ ►Feedback from funding boards at all stages is meant to be helpful to the applicants ►Applicants should respond to all areas highlighted as necessary by the funding board

100 ‘Common pitfalls’ ►Inconsistent accounts of planned research ►Incorrect or inconsistent numbers e.g. sample size calculations ►Apparent lack of awareness of major or related work in train ►Insufficient detail, or muddled detail particularly in the methodology sections – even at full proposal ►Gaps in expertise on the research team – even after feedback from funding board

101 ‘Common pitfalls’ ►Inadequate detail given on the health issue ►Inadequate detail given on the intervention to be evaluated ►Application has not stuck to remit and/or the brief ►Application has not paid enough attention to board feedback between outline and full proposal ►Unrealistic / inaccurate costings (both under and over- costing) ►Submissions have not been proof-read

102 Thank you


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