Published: 01 March 2021
Version: 3.0 - November 2022Print this document
The NIHR Research for Patient Benefit (RfPB) programme will fund research that presents a clear trajectory to patient benefit. Our Regional Advisory Committees would expect to see this pathway to impact clearly explained, even in cases where the patient benefit may not be immediately realised.
RfPB Committees will also balance the likelihood of achieving patient benefit against the cost of the proposal. If the proposed study has a higher risk of failing to achieve patient benefit, or is likely to require further research beyond the end of the award to achieve patient benefit, then a lower cost would be expected if it is to offer value for money.
For example, clinical trials represent a high likelihood (low risk) of achieving patient benefit because, if properly designed and conducted, they provide a clear answer to a clinical question which can then be translated into a change in clinical practice. Feasibility study and other studies conducted in preparation of a full trial, however, would represent a higher risk of failing to achieve patient benefit, as they have a higher risk of failure, and even if they are successful, they would require a further clinical trial to be conducted in order to achieve patient benefit. More upstream research such as intervention development work, evidence synthesis or proof of concept research represents an even higher risk of failing to achieve patient benefit, as it has both a high risk of failure and a longer pathway to potential impact.
RfPB encourages applications in a wide range of topics, costed appropriately to reflect the likelihood of achieving patient benefit. The tiers in the RfPB programme are defined as:
Research that has a clear and close trajectory to patient benefit. The programme has an upper limit of £500,000 (for up to 3 years) for research costs and all applications must fall within this limit.
Feasibility studies, along with other preparatory research towards full trials, such as pilot studies would normally be expected to cost less than £250,000. As described in our updated guidance on applying for feasibility studies, depending on the extent of uncertainties that such preparatory research proposes to resolve we expect that it would be priced accordingly and so we provide examples of previously funded feasibility studies awarded funding under tier 2 or tier 3.
More upstream research with a longer pathway to patient benefit would be expected to cost less than £150,000.
Examples of studies that might fall within this category of ‘higher risk’ research include:
- 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
- Methods development
- 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
- Proof of concept studies.
For more information about the types of studies that fall within the Tier 3 funding envelope, please see the RfPB Review of Tier 3 Funding.
In summary, it may be helpful for applicants if they work within three cost tiers for their research:
- up to £500,000 for research that might have fairly immediate patient benefit (such as a randomised controlled clinical trial),
- up to £250,000 for research in preparation for full trials, including feasibility studies and pilots depending on the extent of uncertainties,
- up to £150,000 for more upstream research, such as observational studies or proof of concept studies, that will generate results that may be useful for more downstream investigations or might carry a higher risk of failing to achieve patient benefit.
These are not fixed cost limits but indicative ranges. Costs will be accepted if they are well justified and demonstrate value for money in terms of the potential for realising patient benefit.