Efficacy and Mechanism Evaluation
The Efficacy and Mechanism Evaluation (EME) programme funds ambitious studies evaluating interventions with 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 in the mechanisms of diseases and treatments. EME is a partnership between the MRC and NIHR.
It looks to attract studies with novel methodological designs that deliver results more efficiently, reduce the study timeline, and maximise the knowledge gained. The translational research it supports covers a wide range of new and repurposed interventions, such as diagnostic or prognostic tests and decision-making tools, therapeutics or psychological treatments, medical devices, and public health initiatives delivered in the NHS.
All of our funded projects are eligible for publication in the NIHR Journals Library. This open access resource is freely available online, and provides a full and permanent record of NIHR-funded research.
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’.
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 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 our animal testing page for more information).
Introduction to the EME Programme
We offer a wide variety of assistance during all stages of the research process. If in doubt, please get in touch.
- Do you need help getting started? Contact the Research Design Service.
- Do you want to know if we will fund your idea? Contact the Application and Funding team by email or on 02380 594303.
- Do you need assistance running your study in the NHS? Contact the Study Support Service.