Developing Sight Loss and Vision research questions: a funder’s perspective Anna Tallant Scientific Advisor, HTA programme 23 September 2015 Evaluation, Trials and Studies Coordinating Centre The NIHR Health Research System Faculty Investigators & Senior Investigators Associates Trainees Infrastructure Universities Research Clinical Research Networks NHS Trusts Research Projects & Programmes Patients & Public Clinical Research Facilities, Centres & Units Research Schools Research Governance Systems Research Information Systems Systems NIHR Evaluation, Trials and Studies (NETS) programmes Health Services and Delivery Research Established: 2012 NETSCC: Established: 2008 Public Health Research Established: 2008 Health Technology Assessment Established: 1993 Efficacy and Mechanism Evaluation Researcher-led Funded by the MRC Managed by NIHR Commissioned Funded and managed by NIHR Established: 2008 & 2011 NETS Programme remits EME programme funds research into the clinical efficacy of treatments and tests that have existing proof-of-concept HTA programme funds research on the clinical and cost effectiveness of healthcare treatments and tests HS&DR programme funds research on the quality, accessibility and organisation of health services PHR programme funds research on non-NHS interventions to improve the health of the public and reduce health inequalities Funding streams Researcher-led work stream • Open calls for researchers to apply for funding for their own topics and questions. Commissioned work stream • Designed to met the needs of decision makers within the NHS. • Topics refined and prioritised by experts and commissioning briefs advertised. Examples of funded research What are the most effective treatments for glaucoma and how can treatment be improved? (No 1 in Glaucoma top 10) HTA 12/35/38: Treatment of Advanced Glaucoma Study (TAGS): A multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma (Prof A King, Jan 2014 – Aug 2020, £1.76 million) How safe and effective is laser assisted cataract surgery? (No 7 in Cataract top 10) HTA 13/04/46: A Randomised Comparison of Femtosecond Laser Assisted vs Manual Phacoemulsification Cataract Surgery for Adults with Visually Significant Cataract: The FACT trial (Mr M Wilkins, Sep 2014 – Sep 2018, £1.37 million) Topic identification • External Engagement (Royal colleges, clinical networks, speciality groups, charities) • Stakeholder engagement (e.g. DH, NICE) • Panel members/ Chairs (suggestions and ID activities at panels) • James Lind Alliance Priority Setting Partnerships • Website suggestions • Literature and data base scanning (Cochrane, DARE, NIHR Journals Library final reports) • Capture of NICE research priorities What makes a good research question? • Important to the NHS and its patients • Supported by current evidence • High scientific quality • Feasible • Timely, i.e. research will continue to be relevant following completion of study • Clear and well-defined • Represents value for money Prioritising research Burden of disease Health services Evidence gap Need = frequency x severity x impact of technology x evidence deficit (Discounted for time to produce evidence) Important question on an important topic Issues commonly discussed by the funding boards (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 ! Issues commonly discussed by the funding boards (2) • 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 – clearly justified, especially for % high-cost staff, e.g. clinicians Key points for success • Make an early approach to local RDS or a CTU for advice on application and proposed methodology • Ensure the team has relevant scientific and project management skills, including strong statistical support • Ensure good patient and public involvement from the start • Check fit with remit of relevant programmes (use FAQs) • If unsure, discuss your proposed study with relevant programme before submitting an application Resources for applicants • NIHR Clinical Research Network • Research Design Service (RDS) • INVOLVE • Browse NETS website for study protocols, guidance notes and FAQs • Become a reviewer for NETS programmes • Become a panel member For further information, to apply for funding or to submit suggestions for our commissioned workstreams: www.nets.nihr.ac.uk
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