Efficacy and Mechanism Evaluation
The EME programme is aimed at supporting 'science driven' studies with an expectation of substantial health gain.
EME research is undertaken earlier in the development pathway than HTA research and is undertaken when there is some initial evidence that the technology is efficacious in patients (where proof of concept in humans has already been achieved) but a study is needed to determine definitive proof of clinical efficacy, size of effect, safety and possibly effectiveness. An intervention which is being tested for efficacy must be clearly present in all evaluations, other than diagnostic evaluations.
EME is basically about the efficacy of the intervention but they do encourage studies regarding mechanistics for example sub studies that add extra on how the disease pathway works. Use of surrogate markers is acceptable so can lab studies be but NO animal studies. In the commissioned calls collaborations are essential, large staged projects are looked for with clear go/no go milestones.
Who it's for:
Lead applicants must be based in the UK, otherwise Research Councils UK eligibility rules apply.
Funding:
The annual budget for the programme is £15m. There are no fixed limits on the duration of projects or funding. However applicants should balance the pressing need for the information with the need to follow participants up for long enough to measure important outcomes.
Process:
The EME Board meets three times a year to consider proposals. You may only submit a full proposal by invitation from the EME Board after a preliminary application has been considered or when you are allowed to use the fast-track scheme. Guidance for the second stage application is only available once the 1st stage has been successful. It is vital that the feedback given at the 1st stage is addressed - this can change the application quite considerably. Full applications will be considered at the next Board meeting. Applicants at the preliminary application stage are required to provide
the details of three clinical experts who are suitable and would be
prepared to act as a referee for the proposal. They try to provide funding decisions within 8 months of the call. About 20% of bids go through to the second stage and of those that do about 50% get funded
Criteria:
Research must evaluate the clinical efficacy of an intervention.
Applications will be judged on the following criteria:
- Scientific quality of the proposal
- Feasibility of the study
- Demonstration of necessary skill mix and experience of the team
- Explanation and justification for estimated recruitment rates
- Ethical, legal and social implications have been considered
- Reasonable costs and value for money
EME