1. NIHR Research Design Service London Enabling Better Research Forming a research team Victoria Cornelius, PhD Senior Lecturer in Medical Statistics Deputy Director RDS London

2. Multidisciplinary teams Multidisciplinary team is required to undertake high quality research of national/ international importance Involve team members at all stages of application development Led by a Principle Investigator with substantial research experience (it sometimes ok for less experienced PIs to be supported by an experienced team)

3. Who should be in the team? What’s Research questions are going to be addressed? What components are included? – Health economics – Quantitative assessment – Qualitative evaluation – Changing beliefs/behaviour – Organisational/service deliver assessment

4. Team members Likely core members – Clinical expert in the disease and population being studied – Team member with expertise in the intervention being studied – A patient or member of the public (yes on the team!) As required: Statistician Clinical Trials Methodologist (from CTU ? or elsewhere) Health Economist Health Psychologist Qualitative expert

5. Team Working

6. Do I need a CTU? If undertaking a clinical trial then strongly recommended to obtain support from a registered CTU HTA and EME will expect partnership with CTU Pilot and feasibility stage? KCTU offer a range of services and are occasionally able to become co-applicants Discuss your grant application with them early CTU models of working vary nationally List of registered CTU http://www.ukcrc.org/infrastructure/ctu/ http://www.ukcrc.org/infrastructure/ctu/

7. How do I find these co-applicants? Its not easy! Sometimes RDS can help If you have CTU support they may be able to suggest Ask around. There may be suitable members in your department or approach the relevant department in your university If you fail to find what you are looking for cost in some external consultancy

8. Balancing costs All funding committees are looking for ‘Value for money’ Map out roles and responsibilities – Ensure you only cost required grade to undertake these duties Limit Senior input time to provide oversight If necessary negotiate with your co-applicants However, be realistic about the time required – 1% FTE equates to 2-3 working days per year

9. NIHR Research Design Service London Enabling Better Research NIHR funding streams and study design Victoria Cornelius, PhD

10. What's in a name? NIHR (agreed by EME, PHR, HTA and RfPB) have very clear definitions for study design Diagnostic Utility, Diagnostic Accuracy Feasibility study, Pilot study

11. Diagnostic studies Diagnostic test: indicator or predictor of disease Can include: diagnostic test, screening test, treatment monitoring Development of a test (MRC, possibly i4i) Diagnostic accuracy: examine the clinical validity of a test (typically RfPB) (observational where often participants undertake ref and new test; no controls required; Outputs expected are Se, Sp, PPV, NPV) Diagnostic utility: examine the value of test in improving patient outcomes (typically EME HTA) (often RCT design)

12. Pilot Studies Pilot studies are a smaller version of the main study Used to test whether the components of the main study can all work together It resembles the main study in many respects, including an assessment of the primary outcome Data from the pilot phase may contribute to the final analysis: internal pilot (but must be planned in advanced) Study should not be powered to detect a statistically significant difference Clear progression criteria to the substantive study should be described

13. Feasibility studies “Can this study be done?” Typical aims include: Estimate standard deviation of the outcome measure (do you really need to do this?) willingness of participants to be randomised; willingness of clinicians to recruit participants; number of eligible patients, carers or other appropriate participants characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure; follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc. availability of data needed or the usefulness and limitations of a particular database time needed to collect and analyse data What is it you don't know such that you can’t design the main trial?

14. RfPB Reluctant to fund pilot studies Rationale : Working with the NIHR definitions all pilots should be ‘internal pilots’ and this unlikely to afforded within RfPB so go to HTA or EME To speed up pathway to patient benefit If you cant design the substantive trial at the pilot stage then what is it you don't know? This is then a ‘feasibility study’ Trying to stop funding ‘underpowered’ trials that are not subsequently followed up with substantive trial. Phase II ( surrogate end points) decision not so clear

15. feasibility External Pilot Substantivefeasibility Internal Pilot Substantive