1. 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

2. Overview 11.00-11.10Welcome and overview (Prof Keith Abrams) 11.10-12.00Overview of NIHR training awards (NIHR Trainees Coordinating Centre) 12.00-12.10Reflections of a non-medical professional (Ms Melanie Baker) 12.10-12.20Reflections of a medical professional (Dr Manish Pareek) 12.20-12.30What the RDS can offer an NIHR application? (NIHR Research Design Service) 12.30-12.40Reflections of an NIHR Senior Investigator (Prof Keith Abrams) 12.40-13:00Questions and answers 13:00Networking lunch

3. Perspectives from a NIHR Senior Investigator & Panel Member Keith R Abrams Department of Health Sciences University of Leicester, UK keith.abrams@le.ac.uk NIHR Leicester, March 2016

4. 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, 2014-15) 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.

5. 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)

6. 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)

7. 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)

8. Member, Research for Patient Benefit (RfPB) Programme Committee (East Midlands) [2006 - 2009] Member, HTA Clinical Evaluation &Trials Board [2007 - 2011] 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 [2013 - ] Chair & Member, DMC, NIHR HTA-Funded MASTER Trial, University of Bristol [2013 -] NIHR - Panel Member

9. 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

10. 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

11. Talk to as many people as possible … including Senior Investigators (there are 11 of us in East Midlands – see www.nihr.ac.uk/our- faculty/directory.htm )www.nihr.ac.uk/our- 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 …

12. Thank You & Questions?