Top Tips - EME

AIM

• 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.
• Includes hypotheses-driven research to improve the understanding of the mechanisms of actions of interventions (interaction between treatment and disease).
• Supports translational research into a wide range of new or repurposed interventions.
• Funds clinical validation studies of diagnostic tests that have been developed and are known to work in the lab.
• Standalone mechanistic studies can be funded as long as they are added on to an existing NIHR-funded study.

Funding

Average cost £1 million (£150,000 - £3 million) over an average duration of 42 months.

Process

Send an A4 summary in PICO format (with intro and background) to the panel to see if in remit:

• Population you are interested in
• Intervention
• Control treatment
• Outcome measure you are using

Tips for success

• Design

Study should be optimised around the most important research question.

Clear rational, show what is known and unknown in the research area. Note the health need has to be in the UK and the solution/outcome needs to benefit the NHS

• Proof of Concept

All applications must cite evidence that the intervention could work from studies involving patients and may include epidemiological data, use of intervention in different conditions and early stage clinical studies. The amount of proof of concept needed varies with the scale of the study and size of funding sought.

• Team

Appropriate skill mix, with a credible mix of clinicians, applied health researchers, statisticians, experts in study design, patients and project managers.

Co-investigators should be making a clear contribution without duplication to demonstrate value for money.

Evidence of good research track record provides confidence in the team.

Important to have CTU input from early in the development stage.

• Collaborations

EME are keen to see collaborations and expect at least 2 of the following organisation types to be involved: NHS, academia and industry.

• Public involvement

PPI co-applicant is common but not essential on your EME bid and remember to justify their role in your application. Even without a PPI co-applicant it is crucial that it’s visible that the public have been consulted in the design process and that there are plans for continual input once funded.

• Outcome measure

Choose a primary outcome that is patient centred and reflects the study question.

It is important that you can measure the outcome in all people in the study.

• Pilot data

It is important to provide relevant existing data about the population to be studied and your primary outcome measure to justify the study.

The panel is interested in information about the incident of the disease in the population, where possible the anticipated effect size of the intervention and likely recruitment numbers. Such data can all be used to justify the sample size.

• Sample size:

Always justify your sample size, give enough information so that the sample size can be reproduced and is easy to understand.

Make sure the effect size is sufficient to change practice and is clinically meaningful and credible.

• Recruitment plan

Provide a detailed recruitment plan based on data.

Make sure you are looking at numbers who have the condition and fit the study eligibility criteria.

Very few trials manage to recruit more than 50% of eligible patients!

Include an allowance for loss and put in place measures to minimise losses (losses have the potential to create bias).

Involve patients in developing measures to minimise loss as they have a good insight into what’s achievable.

• Mechanistic evaluation

Where appropriate, the programme encourages hypothesis-testing mechanistic studies integrated within the main efficacy study which should be hypotheses driven and aimed at (1) advancing scientific understanding of a clinical condition or therapy action or (2) furthering advances of health outcomes for the patients.

Mechanistic evaluations need to have the same rigour in design and clear objectives to the same standards as the efficacy evaluation part of the study.

Often mechanistic evaluations fail to meet the EME remit by being far too exploratory, focusing on biomarker discovery or failing to have the correct team in place.

• Finance

Show good value for money.

Provide a realistic estimation of cost - don’t over estimate staff costs and underestimate non-staff costs, placebos can be expensive!

Note that even when funding has been agreed it can take up to 9 months to go through the contract process as often there are multiple IP issues involved that need addressing.

Author: Shaun Barber     Created: January 2019    Last Updated: December 2022