The EME Programme invites proposals for hypothesis driven research into the underlying mechanisms of action of clinical and public health interventions. Studies must utilise patients or samples from identifiable cohorts from current or completed NIHR-funded projects from the following programmes: i4i, EME (including the MRC/NIHR transferred portfolio), HS&DR, HTA, PHR, RfPB and PGfAR).
Proposals will be accepted across a wide range of interventions; including behavioural, pharmaceutical, psychological, surgical and public health interventions. The research should be hypothesis driven, relevant to the intervention and outcomes proposed by the original study and add significantly to the scientific understanding of the mechanisms of action of the intervention.
The proposed research may involve the analysis or reanalysis of previously stored specimens or data, or the collection of new specimens or new data for additional analysis, provided it is obtained from the study participants. Applicants must have agreement from the CI of the original NIHR study.
Discovery of new biomarkers is not within the remit of the EME Programme.
Applicants will need to make a strong case for how a better understanding of the mechanisms of action will potentially contribute to the future use or development of the technology, future wealth creation and for the ultimate benefit of individual patients’ or the wider NHS.
The EME programme WILL support:
- Research to determine proof of clinical efficacy, size of effect, and long-term safety in a well-defined population.
- The evaluation of a broad range of interventions that have the potential to maintain health, treat disease or improve recovery.
- Hypothesis-testing research based on an efficacy study, to explore the mechanisms of action of interventions, causes of differing responses or disease mechanisms. These studies use data or samples obtained and stored from both treatment and control groups of a clinical study, to arrive at conclusions that would not arise from a simple cohort study.
- Proposals that include a series of linked stages (usually 2 to 3) with progression to the main clinical evaluation dependent on the outcome of the previous stage(s). The criteria for progression must be clearly defined. The main clinical evaluation should require more than 75% of the total project costs and commence within 18 months of the project start date.
- Pilot and feasibility studies where the main study would be within the remit of the EME programme. These studies may be either stand-alone or can be the initial part of a staged project that includes the main clinical evaluation as a subsequent stage.
- The limited steps needed to progress the development of an intervention to a stage suitable for use in an accredited clinical service when included as an initial stage prior to commencing the main clinical evaluation.
- Studies using novel or infrequently-used study designs that increase the value of a study, by maximising the chances of demonstrating the benefit of an intervention, increasing the knowledge that can be gained through the study, or by making the study more efficient.
- The EME Programme welcomes studies adopting novel and efficient study designs or that include the development or testing of new methodologies in an embedded methodological study (EMS). Where delivery of the EMS is integral to the main efficacy trial the additional costs should be modest and the purpose should be to explore issues that may potentially increase the efficiency of trials and value for money. The proposed work should be included in the EME application. Where the EMS requires more substantial funding and can be delivered independently from the running of the main trial, then applicants might wish to consider applying to the MRCNIHR Methodology Research Programme (MRP). http://www.mrc.ac.uk/funding/browse/methodology-research-programme/ Any such application would be independent of the application to the EME Programme. For more information please contact the MRP programme: MRPGrants@headoffice.mrc.ac.uk
The NIHR is holding webinars to support applications to this funding opportunity on:
Monday 01 October 2018; 11:00am – 12:00pm
Monday 08 October 2018; 11:00am – 12:00pm
Visit funding web page