The EME Programme funds ambitious studies evaluating interventions that have the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care. Within these studies EME supports research to improve the understanding of the mechanisms of both diseases and treatments.
The programme supports translational research1 evaluating a wide range of novel or re-purposed interventions. The interventions may include diagnostic or prognostic tests2 and decision-making tools, drugs or biological compounds, psychological treatments, medical devices, and public health initiatives delivered within the NHS.
The EME Programme primarily supports clinical trials, and other robustly designed studies that test the efficacy of interventions. The interventions should have the potential to improve patient care or benefit the public. The programme will only support studies where there is sufficient evidence that the intervention might work in man, i.e. that there is ‘proof of concept (pdf, 55.19 KB) ’.
Innovative study designs involving stratification, the use of routinely collected digital data or novel methodologies are strongly encouraged.
Where appropriate, the programme encourages hypothesis-testing mechanistic studies (pdf, 124.55 KB) integrated within the main efficacy study. These studies could explore the mechanisms of action of the intervention, the causes of differing responses, or promote an understanding of any potential adverse effects and how these could be reduced; they could also contribute to understanding of the disease. The programme will also support mechanistic studies that follow on from on-going or completed clinical studies funded by the NIHR which can use data or samples from these studies.
The programme will accept applications for studies that use clinical or well-validated surrogate outcomes. It will also consider studies that validate potential surrogate outcomes against a primary clinical outcome, within the main clinical trial.
The EME Programme will support:
- Research to determine proof of clinical efficacy, size of effect, and long-term safety in a well-defined population.
- The evaluation of a broad range of interventions that have the potential to maintain health, treat disease or improve recovery.
- Hypothesis-testing research based on an efficacy study, to explore the mechanisms of action of interventions, causes of differing responses or disease mechanisms. These studies use data or samples obtained and stored from both treatment and control groups of a clinical study, to arrive at conclusions that would not arise from a simple cohort study.
- Proposals that include a series of linked stages (usually 2 to 3) with progression to the main clinical evaluation dependent on the outcome of the previous stage(s). The criteria for progression must be clearly defined. The main clinical evaluation should require more than 75% of the total project costs and commence within 18 months of the project start date.
- Pilot and feasibility studies where the main study would be within the remit of the EME Programme. These studies may be either stand-alone or can be the initial part of a staged project that includes the main clinical evaluation as a subsequent stage.
- The limited steps needed to progress the development of an intervention to a stage suitable for use in an accredited clinical service when included as an initial stage prior to commencing the main clinical evaluation.
- Studies using novel or infrequently-used study designs that increase the value of a study, by maximising the chances of demonstrating the benefit of an intervention, increasing the knowledge that can be gained through the study, or by making the study more efficient.
The EME Programme will not support:
- Large effectiveness studies that test the impact of the introduction of an intervention in the wider NHS.
- Hypothesis-generating studies based on sample or data collections from patient cohorts.
- Confirmatory studies, equivalence studies, 'confidence in effect' studies or studies of incremental modifications to existing interventions.
- Research into areas where the health need is primarily outside the UK.
- Any research involving animals or animal tissues (see the NIHR research page for more information).
For more detailed information on the studies the programme supports, please visit the portfolio page. In addition to the researcher-led funding calls the EME Programme often seeks studies into specific diseases or treatments. These Commissioned calls have a brief containing details of the remit of the area of interest and the studies sought. Current calls can be found here. If you are still unsure if your planned research falls within our remit, please contact us.
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