An Introduction to the NIHR Evaluations,Trials and Studies

An Introduction to the NIHR Evaluations,Trials and Studies

An Introduction to the NIHR Evaluations,Trials and Studies funding Phil Taverner, Assistant Director Sarah Puddicombe, Assistant Director Chloe Gilbert, Senior Programme Manager Evaluation, Trials and Studies Coordinating Centre 16/11/2015 Overview NIHR Strategy Which NETS programme What makes a good application NIHRs Strategic Aim To improve the health and wealth of the nation through research NIHRs Strategic Vision To create a health research system in which the NHS supports: outstanding individuals working in world-class facilities conducting leading-edge research focused on the needs of patients and the

public NIHR Infrastructure Added Value in Research NIHR Evaluation, Trials and Studies (NETS) programmes Health Services

and Delivery Research Established: 2012 NETSCC: Established: 2008 Public Health Research HS&DR Established: 2008 Health Technology Assessment HTA Established: 1993

EME PHR Efficacy and Mechanism Evaluation Researcher-led Funded by the MRC Managed by NIHR Commissioned Funded and managed by NIHR Established: 2008 & 2011

Which NETS programme? EME exploratory trials, less pragmatic, phase 2-3, efficacy, mechanisms if possible HTA systematic reviews, large multicentre pragmatic trials or other studies (phase 3-4), effectiveness in the NHS HS&DR organisational, patient experience, qualitative or other PHR effectiveness and cost effectiveness of non-NHS interventions to improve public health MRC-NIHR Efficacy and Mechanism Evaluation (EME) 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 EME will support clinical trials and evaluative studies in patients that; provide definitive evidence of efficacy of healthcare interventions add significantly to understanding of disease mechanisms break new ground new scientific or clinical principles include validated surrogate markers as indicators of patient outcomes EME will not support;

incremental modifications or refinements of existing technologies proof of concept, proof of mechanism in humans (i.e. early phase clinical trials) or confidence in effect studies Characteristics of EME research

Primary research only Evaluates efficacy, safety and possibly effectiveness of an intervention under ideal conditions Clinical trials or evaluative studies (not necessarily RCTs), may also include mechanistic studies which: Are fully worked up and embedded in the main study Are hypothesis driven with a feasible research question Aim to advance scientific understanding of the disease mechanism or the mechanism of action of the treatment Small to large number of participants may include stringent eligibility criteria Technologies are usually mostly developed and defined, but may require some refinement/fine tuning Likely to include placebo as a comparator but could be usual care or the best active alternative

EME project examples Molecular selection of therapy in metastatic colorectal cancer: a molecularly stratified randomised controlled trial programme (FOCUS 4) Prof Tim Maughan 3.5million (84 months) (CARDIFF, Co-applicants, Richard Adams, Bharat Jasani, Rachel Butler) Probiotic to Reduce Infections iN CarE home Service userS (PRINCESS) Prof Chris Butler 1.8million (39 months) (Co-applicants from Cardiff University, South East Wales Trials Unit and Public Health Wales) Clinical Efficacy and Mechanistic Evaluation of Aflibercept for Proliferative Diabetic Retinopathy (CLARITY) - Prof Sobha

Sivaprasad 1.2million (36 months) (Co-applicant, Bangor University, Rhiannon Tudor Edwards) NIHR Health Technology and Assessment (HTA) programme 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 a health technology? 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.

What are health technology assessments? Large-scale evidence syntheses Pragmatic trials Diagnostic evaluation studies Short reports Miscellaneous others Characteristics of HTA Research Funds both primary and secondary research. For primary research: Usually pragmatic research evaluating effectiveness in a real-world NHS setting Multidisciplinary and multi-centre generating results that are generalisable to the NHS Generally a large number of participants, adequate to assess

minimally clinically important differences from a patient perspective. Participant eligibility criteria are wide and representative of the UK population and represent the mix of patients likely to be seen in normal clinical practice Usually evaluate a fully defined and developed technology, compared to the best active alternative or usual care. Placebos may be used in conjunction with best treatment to blind trial participants Usually include cost effectiveness or cost utility Feasibility and pilot studies are eligible HTA Project Examples ANti-psychotic Drug REduction in primary care for Adults with Learning Disabilities (ANDREA-LD): A Randomised Double-blind Placebo Controlled Trial

Prof Michael Kerr, Cardiff University 1.4million (39 months) Developing a multidisciplinary rehabilitation package following hip fracture. Acronym: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) Dr Nefyn Williams, Bangor University 500,000 (39months) Seal or Varnish? A randomised trial to determine the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay Prof Ivor Chestnutt , Cardiff University 1.3million (60 months)

NIHR Health Services & Delivery Research (HS&DR) Programme Purpose and Remit The HS&DR programme funds research to improve the quality, effectiveness and accessibility of the NHS, including evaluations of how the NHS might improve delivery of services. The audience for this research is the public, service users, clinicians and managers. NIHR Health Services & Delivery Research (HS&DR) Programme Principles

The programme will support a range of types of research including evidence synthesis and primary research Keen to support a variety of ambitious evaluative research to improve health services, on topics of national importance Pilot and feasibility studies considered Projects which look at the relevant areas of social care as well as health will be considered No cap to funding, instead appropriate costing and value for money NIHR Health Services & Delivery Research (HS&DR) Programme We support: Research into any aspect of health service quality, accessibility and effectiveness, as long as its importance to the NHS can be clearly demonstrated

Any methodology: qualitative, quantitative, mixed-methods, RCT Studies which will generate national learning generalisable findings, and actionable results (multi-centre, regional, nationwide, international with useful learning and implementable outcomes) We do not support: Low importance Single site/ local studies Service developments, audits or needs assessments Basic scientific or epidemiological research on the causes of disease Testing of new health technologies or diagnostic techniques (HTA) Establishment of a database, as an end in itself PhD studentships HS&DR project examples

The transition from paediatric to adult diabetes services: what works, for whom and in what circumstances? Prof Davina Allen , Cardiff University 380,000 (49months) Integration of social care staff within community mental health teams Prof Peter Huxley, Swansea University 200,000 (48months) Evidence into practice: evaluating a child centred intervention for diabetes medicine management Prof Jane Noyes, Bangor University 600,000 (54months)

NIHR Public Health Research (PHR) programme Purpose and Remit The PHR programme 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. The scope of the programme is multi-disciplinary and broad covering a range of public health interventions. NIHR Public Health Research (PHR) programme Funds the evaluation of non-NHS interventions intended to improve

the health of the public and reduce inequalities in health Unable to fund intervention costs National programme open to researchers from across the UK Includes qualitative and quantitative research which evaluates the effectiveness and cost-effectiveness of public health interventions Primary outcome measure must be health related NIHR Public Health Research (PHR) programme What Public Health Research Adds: Evidence for Education Teacher training and school environment to promote health Building social and emotional wellbeing Promoting physical activity

and healthy diet Preventing smoking, alcohol and substance misuse NIHR Public Health Research (PHR) programme What Public Health Research Adds: Evidence for Local Decisions Urban regeneration and health Community engagement and disadvantaged communities Alcohol environment

NIHR Public Health Research (PHR) programme What Public Health Research Adds: Evidence for Environmental Health Transport urban motorway, free bus travel, active and sustainable travel Housing quality and energy efficiency Effect of reducing street lighting on crime and road accidents PHR project examples Health impact, and economic value, of meeting housing quality standards Prof Ronan Lyons, Swansea University

540,000 (66months) Change in alcohol outlet density and alcohol-related harm to population health (CHALICE): A comprehensive record-linked database study in Wales Prof David Fone, Cardiff University 420,000 (34months) Adapting and piloting the ASSIST model of informal peer-led intervention delivery to the Talk to Frank drug prevention programme in UK secondary schools (ASSIST+Frank): an exploratory trial Prof James White, Cardiff University 500,000 (31months)

Any Questions? What makes a good NIHR application? Evaluation, Trials and Studies Coordinating Centre 16/11/2015 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 & 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 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) Project funding Full & Appropriate Funding no upper limit on the amount of funding granted for a project. University based projects: up to 80% of the Full Economic Cost (FEC). NHS Trust based projects: 100% of the direct costs. Other organisations are also welcome to apply.

Commissioned of Researcher-led? All programmes offer both workstreams Researcher-led Commissioned 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 Contact the programme in case of query email in summary for remit advice

Choose the right question Has it already been answered? Has the funding stream funded similar research? Does it matter to patients?

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? 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? Is it worth investigating cost-effectiveness? Would a mixed methods or qualitative study be appropriate? Use check lists: CONSORT, SPIRIT, EQUATOR Pick your team carefully Seniority of PI Consider involving a CTU Comment on track record and experience of team 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) PPI Be careful of having too many chiefs! 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 Think about who you are writing for Simple English for mixed audience Clinical, methodologists, reviewer, panel /board Patient and public Tell the story well for the non-expert Follow the writing guides/ Newspaper style Clear plain English summary - Understandable to any member of the public or panel Visible headings (e.g. sample size, outcomes, technologies)

Create white space use paragraphs Flow diagrams PROOF-READ SUBMISSIONS CAREFULLY! 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 Include public and patents (and pay them) Public and Patient involvement (PPI) matters to the NIHR - consider it carefully and justify your decisions Questions from the application form:

Were patients and the public actively involved in identifying the research topic or prioritising the research questions? If not why not? Were patients and the public actively involved in preparing this application? If yes to either or both of these questions, please give details. Describe how patient and public involvement has informed and/or influenced the development of the application and how patients and the public have been involved. If no to either or both questions, 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

Have an imaginative plan for dissemination 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 Consider working with stakeholders to develop your dissemination plan Be creative and plan to target all audiences (not just publications - movie, website, social media )

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 Tips for success Read the detailed brief , call guidance notes & FAQs Check application fits within the programme remit Check the existing portfolio of research http:// and UKCRN portfolio: Demonstrated PPI and good quality plain language summary Proof read application Dont leave it to the last minute ! Get help CTUs, RDS, research networks Patient groups & INVOLVE Appropriate methodologists/Statisticians Web resources Guidance notes, tips for success in applying Contact us were friendly and helpful

Any Questions? Where can I find help? For more information, visit: Enquiries welcome: Adding Value in Research:


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