This guide outlines which sorts of primary research studies will be of interest to the Invention for Innovation (i4i) Programme, or the Efficacy and Mechanism Evaluation (EME) Programme (an NIHR and MRC partnership).
i4i research: The Invention for Innovation (i4i) Programme 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 research: The 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.
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| 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.
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| 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.
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