19/62 Epigenetics

Applications are sought for research to evaluate the use of epigenetic biomarkers for the detection, diagnosis, or establishing the prognosis of a disease or condition.

Areas of interest include, but are not limited to:

• evaluations of therapies and management strategies guided by assessment of epigenetic markers for the treatment of disease
• the use of epigenetic markers as a screening tool in a selected or general population

Clinical validation of existing biomarkers (i.e. studies of biomarkers that have already undergone initial validation and shown signal strength and specificity) is within the scope of this call but early validation and the discovery of novel biomarkers is excluded.

Applicants may wish to consider the role of epigenetic biomarkers within the context of a P4 (predictive, preventative, personalized and participatory) systems medicine approach.
Applications for phase 2b studies of modest size and cost are encouraged. Applicants are encouraged to consider opportunities to embed the testing of mechanistic hypotheses within the main study. Also of interest are standalone studies of the mechanisms underpinning interventions (investigational or control) used in existing CSO- and NIHRfunded trials, although applications in this area should refer to the EME Mechanisms of Action of Healthcare Interventions call.

Applications are expected to set out programmes of work which may contain distinct stages. It is expected that the initial stages of the study will, if successful, lead onto a full evaluative
clinical study or trial, which is in the remit of the EME Programme. This study must also be included and clearly specified within the application. Clinical trials embedded within the
programme of work must be large enough to detect a meaningful effect.

Applications to this call may include initial stages such as:

• The limited steps needed to progress the development of an intervention to a stage suitable for use in an accredited clinical service;
• Prospective clinical work or retrospective research utilising existing big data or clinical samples to inform the main study;
• Pilot or feasibility studies.

As a rough guide it is expected that these initial stages will be complete within the first 18 months of the project and must not contribute more than 25% to the total cost or duration of
the project.

Applicants will need to make a strong case for the future importance of the intervention through providing a measurable positive impact on health, innovation or future wealth creation and for
the ultimate benefit of individual patients’ or the wider NHS. Applicants should read the details of the EME remit at https://www.nihr.ac.uk/eme

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