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NIHR Research Design Service London Enabling Better Research

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

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NIHR Research Design Service London Enabling Better Research

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

  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/

  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 LondonEnabling Better Research Victoria Cornelius, PhD NIHR funding streams and study design

  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

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