Competition 26 of the NIHR Research for Patient Benefit (RfPB) programme, which launched in October 2014, saw the introduction of three funding tiers to provide guidance to applicants in terms of the amount of funding the programme would be willing to put towards certain types of research.
The overarching message was that RfPB Committees would balance the probability of a proposal achieving patient benefit against the cost requested, meaning RfPB would be willing to put more funding towards a proposal which had a clear and close trajectory to patient benefit and less funding towards a proposal which was more distant to patient benefit. This was in the context of the programme’s existing funding limit of up to £350k over a duration of up to 36 months.
The aim of the funding tiers was to introduce different types of research into the programme and encourage more innovative and developmental research, which would typically have previously been out of the remit and scope of the programme. The introduction of tier 3 was also in response to feedback that it was challenging to secure funding, especially from research programmes, for developmental research and proposals that were further up the pathway to patient benefit.
Although the programme had informally operated a funding limit of £250k for feasibility studies a more structured approach was detailed, including a whole new third tier.
- Tier 1 (up to £350k) for research that has a clear and close trajectory to patient benefit, such as a definitive trial.
- Tier 2 (up to £250k) for research proposals which are feasibility studies.
- Tier 3 (up to £150k) for research which is on a pathway to patient benefit yet further from it
The programme provided some examples of the type of research which it expected would fall into tier 3:
- Observational studies using clinical databases, which might provide preliminary estimates of an effect size that would be useful in the design of a clinical trial.
- Observational studies to establish for example the practicality and acceptability of changes to clinical practice, or the best means to ensure and measure adherence, prior to a formal evaluation.
- Developing and refining interventions.
- Developing new scales or outcome measures.
- Exploratory studies, e.g. using qualitative methods that might provide insights into an intractable problem.
- Additional follow up of patients in a completed clinical trial.
- Post-market surveillance for unknown side effects of a drug (Phase IV trials).
- A systematic review, especially where the number of relevant studies is likely to be limited.
What has the programme funded under tier 3 to date?
The programme has received a wide range of applications to tier 3 and has funded a diverse range of projects to date.
The funded projects fall into the following research types:
- systematic reviews
- developing and refining interventions
- realist synthesis
- economic evaluation
- secondary data analysis (including developing predictive models and needs assessments)
- diagnostic accuracy studies
Although there is a wide range of research topics and designs funded under tier 3 the programme broadly categorises them into four types of research.
- Therapeutic – concerned with developing and evaluating interventions to improve patient benefit.
- Diagnostic – concerned with ensuring patients are appropriately classified to receive the above intervention
- Needs assessment – concerned with assessing the needs (usually of interventions) in a particular patient population
- Evidence synthesis.
What is the programme expecting from its tier 3 projects?
Being on a pathway to patient benefit the programme anticipates that successful tier 3 studies will lead onto future research, for example feasibility or definitive trials of newly developed or refined interventions. However, the diverse nature of tier 3 projects means that the research will take various pathways to achieving patient benefit.
However, the four broad categories are likely to follow the pathways below:
- Therapeutic: once interventions and appropriate measures are finalised the research would progress to a trial, possibly via a feasibility study
- Diagnostic – early ‘proof of concept’ evidence that a diagnostic marker might perform as well as or better than an existing one would lead to a diagnostic accuracy study in clinical practice or a diagnostic utility trial in which patients would be randomised to two or more diagnostic tests.
- Needs assessment – may lead onto intervention development or service evaluation studies
- Evidence synthesis: less a trajectory and more informs potential studies