EME or MRC? EME or HTA? EME or i4i? Show all Show none

This tool will help you understand whether your proposal would fit best with EME, or different source of funding. Click on the tabs above to discover more.

Would my primary research idea be of interest to the DPFS scheme or the EME programme?

 

DPFS Research: Developmental Pathway Funding Scheme (DPFS) is aimed at providing proof of concept in humans. They are generally supported by pre-clinical evidence (where appropriate).

EME Research: The Efficacy and Mechanism Evaluation (EME) programme supports explanatory trials (later in the development pathway than DPFS), 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 large-scale study is needed to determine definitive proof of clinical efficacy and safety.

 

Characteristic DPFS EME
Evaluates Studies should focus on establishing safety and proof of concept in humans. The principal focus of the study should not be to understand disease mechanism.  Studies should be aimed at establishing clinical efficacy of a therapeutic intervention under controlled conditions which already have proof of concept in humans established.  
Stage of research 

DPFS supports early stage clinical studies up to and including safety and proof of concept in humans. Studies would generally aim to evaluate the treatment in tightly controlled conditions. The development of the intervention may still require some refinement.


Where appropriate, proof of concept in animal models will have been undertaken.
All forms of intervention will be considered, for example drug or cell-based treatments (apart from stem cells), vaccines, devices and instruments, diagnostics, surgical, dietary, psychological interventions, and novel applications of existing therapeutics.

EME research would be specifically designed to evaluate efficacy and whether the treatment works under ideal conditions, but may gather some further information on safety.

 
EME studies would start where proof of concept in humans has already been established and where the required intensity/level/dose of an intervention has been decided.

Design A clinical study. Studies may be proposed with multiple “phases”, where there are clear and measurable milestones between them, which must be met in order to progress to the next phase.    A large-scale clinical trial or evaluative study (not necessarily an RCT). May also include laboratory based (or similar) studies embedded within the main EME study. 
Participant eligibility criteria  Relevant patient groups or healthy volunteers.    Relevant patient groups: often narrowly defined by the entry and exclusion criteria, and not necessarily representative of the UK population as a whole. 
Technology* A new intervention (or a new indication for an existing intervention) which requires proof of concept (or safety) in humans.  Mostly developed and defined but some refinement / fine tuning may still be needed. 
Outcome Measures  Studies will demonstrate proof of concept in humans and may include surrogate outcome measures or safety.  The research will provide supporting data for a large scale evaluative trial.    Validated surrogate markers as indicators of health outcome are acceptable.  The output may provide the justification for a pragmatic trial. 
Animal studies  Can be included where pre-clinical toxicology/ manufacture/ scale-up work is required to enable the proposed trial to be undertaken.  Research involving animals is not supported 
Can a mechanistic evaluation be included as part of the main study?  The principal focus of the clinical study should not be to understand the aetiology or mechanism of a disease. However, opportunistic mechanistic work is encouraged.  A significant proportion of the research should involve human participants.   Mechanistic evaluations which help to understand how an intervention works, or how behaviour affects or is affected by an intervention, may be included as part of the main EME study. 
Diagnostic evaluations Likely to support the development of a diagnostic test.  Unlikely to support the validation of a diagnostic test. 

Likely to support validation of a diagnostic test.


Unlikely to include clinical utility evaluations which seek to determine the effects of introducing a new diagnostic test into clinical practice.

*By “technology” we mean any method used to promote health, prevent and treat disease and improve rehabilitation or long-term care. “Technologies” in this context are not confined to new drugs but include procedures, devices, tests, settings of care, screening programmes and any intervention used in the treatment, prevention or diagnosis of disease.

Would my primary research idea be of interest to the HTA programme or the EME programme?

 

HTA Research: The Health Technology Assessment (HTA) programme supports research that is immediately useful to clinical practice and policy/decision makers. HTA research is undertaken when there is evidence to show the technology is efficacious but there is uncertainty around its clinical and cost effectiveness in a real life NHS setting in comparison to the current best alternative(s). There may also be uncertainty around its place in the existing care pathway.

EME Research: The Efficacy and Mechanism Evaluation (EME) programme supports research that is designed to advance scientific knowledge. 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. 

Characteristic HTA
EME
Evaluates Effectiveness of a medical intervention in a real life NHS setting. Efficacy, safety and possibly effectiveness of a medical intervention under ideal conditions.
Types of research Primary (clinical research). Secondary (evidence synthesis, e.g. a systematic review or meta analysis). Usually pragmatic research with routine care. Primary (clinical research). Usually exploratory research with expert care.
Stage of research 

HTA research would normally follow that which is suited to the EME programme, however there is some overlap with the later stages of EME research. 


The main focus of HTA research is long-term effectiveness and the impact on patients’ quality of life as well as cost effectiveness. These studies would evaluate effectiveness in a real-world NHS setting.

EME would consider research which has already been successful in the first stages of testing in humans (often volunteers), and where the required intensity/level/dose of an intervention has been decided
EME research would be specifically designed to evaluate efficacy and whether the treatment works under ideal conditions, and may gather further information on safety.
Design Often a pragmatic randomised controlled trial although other study designs may be used for instance in the evaluation of diagnostic tests. A clinical trial or evaluative study (not necessarily an RCT). May also include laboratory based, or similar studies that are embedded within the main EME study. 
Participant eligibility criteria  Wide and representative of the UK population and reflects the mix of patients likely to be seen in normal clinical practice.    More stringent and not necessarily representative of the UK population.
Number of participants and centres Generally large – adequate to assess minimally important differences from a patient perspective; usually multi-centre generating results that are generalisable to the NHS. Small to Large - may be single or multi-centre.
Technology* Fully defined and developed technology. Mostly developed and defined but some refinement / fine tuning may still be needed. 
Comparator The best active alternative or usual care. Placebos may be used in conjunction with best treatment to blind trial participants. Likely to be placebo but could be usual care or the best active alternative.
Outcome Measures  Clinically important outcomes that matter to patients and that measure health gain. Validated surrogate markers as indicators of health outcome are acceptable. 
Follow up Sufficient to ensure that a wider range of effects are identified other than those which are evident immediately after treatment. Sufficient for the outcome to be manifest.  When surrogate outcomes are used, for example, this may be shorter than in typical HTA research.
Health economic component included? Usually cost-utility or cost effectiveness. Not usuall.y
Can a mechanistic evaluation be included as part of the main study?  Not usually, it would only be a secondary consideration to assessing cost-effectiveness.   Yes.  Evaluations which help to understand how an intervention works, or how behaviour affects or is affected by an intervention, may be included as part of the main EME study.
Diagnostic evaluations

Unlikely to support evaluations which seek to determine the normal range of values for a diagnostic test through observational studies in healthy people. 


Likely to support the evaluation of cost effectiveness in routine clinical practice.

Likely to support validation of a diagnostic test.

 
Unlikely to include evaluations which seek to determine the effects of introducing a new diagnostic test into clinical practice.

*By “technology” we mean any method used to promote health, prevent and treat disease and improve rehabilitation or long-term care. “Technologies” in this context are not confined to new drugs but include procedures, devices, tests, settings of care, screening programmes and any intervention used in the treatment, prevention or diagnosis of disease.


A key difference between an EME and an HTA study is whether the study can be broadly categorised as either an explanatory or a pragmatic study. Explanatory (or efficacy) studies test interventions under ideal conditions and describe studies that test causal research hypotheses; and Pragmatic (or effectiveness) studies test interventions under usual conditions, and describe studies that help users choose between options for care Thorpe et al, Journal of Clinical Epidemiology, 2009, Volume 62, Issue 5, Pages 464-465, have published the PRECIS tool to assist in understanding these differences and helping in trial design; whilst HTA prioritisation and commissioning boards do not explicitly apply this tool in decision making, it is a useful reference source in preparing your application.

Would my primary research idea be of interest to the i4i or the EME Programme?

 

i4i Researchi4i supports translational R&D projects aimed at cultivating new techniques or technologies into  innovative interventions which address existing or emerging healthcare needs. Up to three years in duration and led by experienced management teams, projects should be informed by evidence already obtained through prior research, or are borne out of techniques or technologies used in sectors other than health. The programme’s key aim is to encourage and provide support for projects which have a strong potential for commercialisation and acceptance for use within the NHS. Projects are expected to have a clear end product in view at all times.

EME ResearchThe Efficacy and Mechanism Evaluation (EME) Programme supports explanatory clinical studies, 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 large-scale study is needed to determine definitive proof of clinical efficacy and safety.

 

Characteristic i4i EME

Purpose

Supports early translational R&D projects aimed at cultivating new medical technologies or techniques into innovative interventions which address existing or emerging healthcare needs.

Supports the evaluation of efficacy, safety and possibly effectiveness of a medical technology.

Technologies

Technologies supported include medical devices, active implantable devices, in vitro diagnostic devices and any intervention used in the treatment, prevention or diagnosis of disease.

 

Technologies would usually still require significant R&D to ultimately enable an advanced prototype of a medical device to be developed.

 

Technologies supported include therapeutics (small molecule and biologic), psychological interventions, public health, diagnostics and medical devices. Treatments or interventions intended to prevent disease are also included.

 

Technologies would usually be fully developed and defined, but some refinement / fine tuning may still be needed

Stage of research

Projects must be informed by evidence already obtained through prior research, or are borne out of techniques or technologies used in sectors other than health.

 

EME research would be specifically designed to evaluate efficacy and whether the technology works under ideal conditions, but may gather some further information on safety.

Usually the technology would already have undergone early testing in humans.

Design

Projects must primarily be R&D focused. Clinical testing on a small scale to obtain first-in-man data, inform the further development of medical techniques or technologies or for regulatory approval purposes could also be included as components of a project.

A clinical trial or evaluative study (not necessarily an RCT). May also include laboratory based (or similar) studies embedded within the main EME study.

Participant eligibility criteria

Participant eligibility for the purposes of undertaking clinical testing on a small scale to obtain first-in-man data, inform the further development of medical techniques or technologies or for regulatory approval purposes could be included as components of a project.

Relevant patient groups: often narrowly defined by the entry and exclusion criteria, and not necessarily representative of the UK population as a whole.

Outcome measures

The development of advanced prototypes of medical devices or medical technologies with associated first-in-man data where appropriate.

Validated surrogate markers as indicators of health outcome are acceptable.  The output may provide the justification for a pragmatic trial.  The outcome measures should demonstrate the benefit of the technology to patients.

Research involving diagnostics

i4i will not support projects which are primarily focused on evaluating or validating a diagnostic test, but will support projects seeking funds to develop a diagnostic device.

 

Likely to support validation of a diagnostic test.

Unlikely to include clinical utility evaluations which seek to determine the effects of introducing a new diagnostic test into clinical practice.

Health economic component included?

This should be included where appropriate information exists to help explain the business case for the development of the medical device or medical technology. 

Not usually, but may be included if appropriate and relevant to the application.