NIHR Research Design Service London
Enabling Better Research
Forming a research team
Victoria Cornelius, PhD
Senior Lecturer in Medical Statistics
Deputy Director RDS London
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)
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
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:
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Statistician
Clinical Trials Methodologist (from CTU ? or elsewhere)
Health Economist
Health Psychologist
Qualitative expert
Team Working
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/
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
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
NIHR Research Design Service London
Enabling Better Research
NIHR funding streams and
study design
Victoria Cornelius, PhD
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
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)
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
Feasibility studies
“Can this study be done?”
Typical aims include:
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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?
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
feasibility
External
Pilot
feasibility
Internal
Pilot
Substantive
Substantive