Researcher-led remit

The EME researcher-led workstream is funded by the MRC.

The EME programme aims to support excellent clinical science with an ultimate view to improving health or patient care.

Broadly, while the Experimental Medicine schemes address the proof of concept and “can it work?” questions, the EME programme examines the efficacy of the intervention (“does it work?”) to the point where, in the example of a drug, a marketing authorisation could be sought or widespread use in healthcare supported. The safety of the intervention is also a subject for the EME programme. The HTA programme considers clinical and cost effectiveness ("is it worth it?").

The remit of the EME researcher-led workstream includes clinical trials and evaluative studies - in patients - which:

• evaluate clinical efficacy of interventions (where proof of concept in humans has already been achieved);
• add significantly to our understanding of biological or behavioural mechanisms and processes;
• explore new scientific or clinical principles;
• include the development or testing of new methodologies.

The EME programme WILL support:

• research which seeks to determine definitive proof of clinical efficacy and size of effect, safety and possibly effectiveness;
• studies that use validated surrogate markers as indicators of health outcome;
• laboratory based, or similar, studies that are embedded within the main study, if relevant to the remit of the EME programme.

The EME programme WILL NOT support:

• confirmatory studies or trials of incremental modifications and refinements to existing medical interventions;
• proof-of-concept, proof-of-mechanism in humans, nor 'confidence in effect' studies;
• research into 'global health', where 'global health' can be defined as 'areas where the health need is identified in developing countries (i.e. including diseases of developing countries), or where the health need does not yet exist in the UK but might in the future and the problem can be best addressed in developing countries';
• research involving animals.

For eligibility criteria for the researcher-led workstream please visit: www.eme.ac.uk/resources/researcher_led_faqs.asp

The EME researcher-led workstream will support research proposals which are important to healthcare, from researchers based across the UK (England, Scotland, Wales and Northern Ireland).