Research Training Opportunities for Medical and Non-Medical Professionals NIHR Research Design Service East Midlands & University of Leicester Clinical Education Centre, Leicester General Hospital 11am, March 14 th 2016

Overview Welcome and overview (Prof Keith Abrams) Overview of NIHR training awards (NIHR Trainees Coordinating Centre) Reflections of a non-medical professional (Ms Melanie Baker) Reflections of a medical professional (Dr Manish Pareek) What the RDS can offer an NIHR application? (NIHR Research Design Service) Reflections of an NIHR Senior Investigator (Prof Keith Abrams) :00Questions and answers 13:00Networking lunch

Perspectives from a NIHR Senior Investigator & Panel Member Keith R Abrams Department of Health Sciences University of Leicester, UK NIHR Leicester, March 2016

Non-NIHR Background Professor of Medical Statistics (been at Leicester since 1994 & chair since 2001) Head of Biostatistics Research Group (6.9 FTE Academic, 9 RAs, 8 PhD students + MSc in Medical Statistics, n=36, ) Research Interests: Statistical methods in HTA & large-scale registry data Current Group funding: £23.5M (£5.8M income to UoL) – main funders include; CRUK, EU, non-UK Governments, Industry, MRC & NIHR (>50%) National Institute for health & Care Excellence (NICE) – Appraisal Committee member since 2007 – Member of Decision Support Unit (DSU) – Consultant to NICE International Consultant to Pharmaceutical Industry Leicester PI: £13M EU/EFPIA IMI GetReal Project - a collaboration between 27 partners (academia, industry, regulatory/reimbursement agencies) and the main objective of which is to explore the use of RWE in HTA decision-making & drug development.

NIHR - Awards (Personal & Training) MSc in Medical Statistics – 4 NIHR studentships pa 2 current NIHR Research Methods Fellow (4 previously) Supervisor to 5 NIHR DRFs (4 previously NIHR RMFs) – Modelling care pathways in neonatal care: costs and consequences for the future. (S Seaton) – Evaluation of interventions for Overactive Bladder and Detrusor Overactivity: Development and application of evidence synthesis methods for extensive treatment networks. (R Owen) – Dynamic clinical risk predictions in personalised medicine: development and application of joint models for repeatedly measured biomarkers and time-to-event data in biomedical research. (M Crowther) – Informing healthcare decision-making in the UK: evidential and methodological implications of the changing pharmaceutical regulatory and pricing landscape for health technology assessment (HTA). (P Dequen) – Adjusting for treatment switching within Health Technology Assessment: Development, evaluation and application of methods of adjustment. (R Boucher)

MSc in Medical Statistics – 4 NIHR studentships pa 2 current NIHR Research Methods Fellow (4 previously) Supervisor to 5 NIHR DRFs (4 previously NIHR RMFs) – Modelling care pathways in neonatal care: costs and consequences for the future. (S Seaton) – Evaluation of interventions for Overactive Bladder and Detrusor Overactivity: Development and application of evidence synthesis methods for extensive treatment networks. (R Owen) – Dynamic clinical risk predictions in personalised medicine: development and application of joint models for repeatedly measured biomarkers and time-to-event data in biomedical research. (M Crowther) – Informing healthcare decision-making in the UK: evidential and methodological implications of the changing pharmaceutical regulatory and pricing landscape for health technology assessment (HTA). (P Dequen) – Adjusting for treatment switching within Health Technology Assessment: Development, evaluation and application of methods of adjustment. (R Boucher) NIHR - Awards (Personal & Training)

Perspectives: – Fellowships – Person, Place, Project & Training – Applicant needs to have ownership of project (& training plan) – Great (& necessary!) to have good & appropriate supervisors … but they won’t be doing it & not at interview!! – Project needs to be motivated by very real clinical problem(s) with identifiable patient benefit – Cannot have too much advice (from a wide range of disciplines/experts, not just your potential supervisors!! ) – Communication is absolutely key, especially to non- subject specialists! NIHR - Awards (Personal & Training)

Member, Research for Patient Benefit (RfPB) Programme Committee (East Midlands) [ ] Member, HTA Clinical Evaluation &Trials Board [ ] Member, HTA Emergency Care Board [2007 – 2008] Member, Post-Doctoral Research Fellowship Committee [2015-] Member, Steering Committee, NIHR Programme for Applied Research: The Design, Development, Commissioning and Evaluation of Patient Focused Vascular Services, University of Sheffield [ ] Chair & Member, DMC, NIHR HTA-Funded MASTER Trial, University of Bristol [2013 -] NIHR - Panel Member

Show that it is an important clinical question with potential for patient benefit, and that it hasn’t already been answered … use a systematic review. A good & appropriate team is essential!! Make sure you have all the necessary skills to undertake the project! If undertaking a RCT – talk to RDS & CTU early on & you must involve a CTU! Research always takes longer than expected - don’t be over ambitious! NIHR – Panel Member Perspectives – 1

A good answer to a simple question is better than a poor one to a complex one! Make things as simple as possible – RCTs in particular should be simple! Most discussion in committee regarding RCTs focuses on feasibility/recruitment! – Consider a feasibility/pilot study or seamless Phase2/3 design Costing: be realistic – research is expensive – Average NIHR HTA RCT in 2011 was >£1.8M PPI – don’t pay lip service … it can be very useful! NIHR – Panel Member Perspectives – 2

Talk to as many people as possible … including Senior Investigators (there are 11 of us in East Midlands – see faculty/directory.htm ) faculty/directory.htm Make it as easy as possible for reviewers to understand what you intend to do! Think about presentation/layout & don’t blind them with science!! Final Thoughts …

Thank You & Questions?