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Experimental medicine for mental health

This call is now closed for applications and is available for reference purposes only.

View details of the outcome of this call

This is an announcement of a new funding call. This call is one of a suite of initiatives and funding opportunities available for mental health and experimental medicine, but is the only one that will focus entirely on pump-priming in the areas of mental health

Proposals for exploratory studies in experimental medicine for mental health (EMMH)
Context and Background
Relationship to other MRC schemes
Assessment criteria
Advice to applicants
How to apply

Proposals for exploratory studies in experimental medicine for mental health (EMMH)

Key points

The aim of this call is to support exploratory studies to provide confidence in concept for novel therapeutic interventions in mental health. The outputs of such studies would inform more definitive studies to be supported through other funding schemes, primarily the MRC Developmental Clinical Studies (DCS) scheme.
This call will support small grants of 2 years duration with a financial value of between £250k and £500k. Costings should be on a full economic costs basis. MRC will pay 80 per cent FEC.
The total budget available for this call is £3m.
The deadline for applications is 4pm on 20 September 2011. Funding decisions will be taken in January 2012.

Context and Background

The call has been launched well in advance of the deadline for receipt of applications (mid September 2011) to allow for a period of academic networking. As partnerships with industry are key to the process of translation, the networking period could be used productively to build small consortium across the field, engaging industry where possible as well as experts from other academic fields. The scope and aims of the call were finalised after a workshop with academics, industry and other key stakeholders. A report of this workshop can be found here.

Scientific Remit

The remit is all areas of mental health and addictions (e.g. depression, anxiety, affective and conduct disorders, learning disabilities and autism and addictions to substances and gambling). It specifically excludes neurodegeneration including studies of dementia and Alzheimer’s disease (see MRC initiatives in this area as advertised on the MRC website).

Scope

This call is limited to research on humans.

It includes:

cognitive, behavioral and/or pharmacological interventions; they can also be cell based treatments; vaccines; devices and instruments; surgical and dietary interventions, and novel applications of combinations of existing therapeutics.
repurposing studies of small molecules
studies designed to be efficient (e.g. shorter duration, fewer patients), that focus on demonstrating confidence in an effect of the drug or intervention, if one exists, which might involve changes in design or analyses guided by examination of the accumulated data at an interim point.
using normal humans as an experimental model for further data on the efficacy of interventions when recruiting patients as a first step might be especially challenging.
support for collaborations, particularly with industry (where the industry partner wishes to pre-negotiate the distribution of IPR generated by the collaboration applications fall within the legislative framework of the EC “Collaborative R&D” scheme – see partnerships below)

The call will specifically exclude:

phase III studies, irrespective of scale and any large scale study of efficacy where proof of principle is already established
animal studies
support for infrastructure or facilities
proposals that already have suitable background for submission to the DCS scheme
toxicology and safety studies (applicants with a promising NCE without such data should contact the Office for advice)
support for small molecule or any other intervention already on the primary development pathway
development and evaluation of biomarkers (though is also a priority need and those wishing to develop biomarkers should contact the Office)

Methodological considerations

Power

We do not anticipate proposals will be powered to provide definitive evidence; they are likely to be based on smaller numbers of participants to inform the design of more definitive studies where providing greater precision on issues such as effect size estimates, patient history and characteristics etc will be expected.

The overall strategy should be to use sufficient numbers of participants to give confidence that the main observed effects were a consequence of the intervention; a series of observations that show a trend in the same direction may be sufficient. Formal power calculations are not mandatory, but applicants are expected to demonstrate rigorously the appropriateness of their experimental design and contain a clear plan for data analysis, relating explicitly to the primary research question. Applicants are reminded that internal validity is the key issue in these studies (see below).

Using innovative experimental medicine to establish confidence in efficacy

At a workshop on experimental medicine, held before this call was launched, delegates raised the real need to demonstrate the efficacy of an intervention at an early stage and therefore not to waste the opportunity afforded by experimental medicine to de-risk the development of interventions prior to later phase studies. It was suggested that studies focus on establishing increased confidence for efficacy in the most innovative, efficient and cost effective way. Such studies should typically:

be exploratory in approach
trade-off external validity for internal validity
maximize signal:noise ratio
use highly and innovatively characterized subjects grouped by common biological characteristics or symptom within a clinical diagnostic category exploiting intermediate outcomes and biomarkers where possible
use staged or multi-modal approaches if resources allow

Relationship to other MRC schemes

This scheme aims to increase confidence in novel intervention for take up by the MRC Development Clinical Studies (DCS) scheme. This schemes supports research across the whole MRC remit. DCS supports early stage clinical investigations on the development pathway for a new therapeutic/diagnostic/device/public health intervention.

Partnerships to enhance translation

Applications including partnerships with industry are strongly encouraged. The nature of the partnerships might involve access to expertise, technologies, reagents, patient groups or co-funding. The MRC Translational Scientist in Mental Health, Dr Jayne Bailey (see contacts below), will broker some of these arrangements but much of the work in establishing these partnerships will need to be done by the academic partners submitting proposals to this call.

The terms of collaboration, particularly in relation to industry, must be determined early in the study development and relevant agreements must be put in place. Partnership arrangements should ensure transparency in the development of the study design and in the analysis and publication of results (including if these are negative). Consideration should also be given to issues such as: relative responsibilities, governance arrangements, regulatory approvals, indemnity, intellectual property rights, reporting and access to data and samples.

The MRC MICA scheme provides a framework for deciding on the level of industry investment in relationship to the ownership of outcomes and data generated. UK companies of any size may participate in partnership with an eligible research organisation. Overseas based companies may also participate, where it can be established that their involvement is necessary for the delivery of the projects aims.

Proposals can fall into one of two categories:

Fully flexible – where there is no required minimum level of industrial partner’s contribution. In this category, IPR generated by the academic partner must be fully allocated to the academic partner; the industrial partner may have a right to negotiate for access (at a fair market price) to the academic party’s IPR but terms cannot be agreed until the conclusion of the collaboration.
Gated contributions - applications in this category fall within the legislative framework of the EC “Collaborative R&D” scheme and apply where the industry partner wishes to pre-negotiate the distribution of IPR generated by the collaboration. Here, the value of the industry contribution must meet a minimum level of contribution of 50% for applied research – see below

For further details see: http://www.mrc.ac.uk/Fundingopportunities/Grants/MICA/Specification/index.htm

Assessment criteria

Demonstrable innovation
Addressing a major health need as identified in the MRC-led review of mental health research, for example, focusing on chronic mental illness
based on a credible scientific rationale that can be traced to the scientific literature (although the provision of preliminary data to establish proof of concept or the efficacy of the intervention is the purpose of this call)
Appropriate or innovative methodology that exploits the opportunity provided by this funding call to de-risk the development of interventions in the most cost effective and efficient manner
Have a clear endpoint but also collect information that can be used to support or refute the proposed mechanism of effect
Inclusion of all required expertise
Demonstrates knowledge and understanding of the regulatory frameworks and Clinical Research Governance
Demonstrates support from partners, such as NHS Trusts and HEI, that the necessary infrastructure and facilities will be made available
Indication of credible future funding strategy (follow-up funding should be sought from the DCS scheme or the Research Grants scheme).

Advice to applicants

This call is a fast track funding stream with a single, full application stage. Applicants should note that because of anticipated demand there will be limited scope for feedback during the assessment process. It is anticipated that proposals generally will be up two years in duration with a timescale and resources appropriate to the research proposed.

How to apply

Proposals submitted against this call must be costed with Full Economic Costing. You should submit your proposal using the Research Councils’ Joint electronic Submission (Je-S) System (https://je-s.rcuk.ac.uk/). Guidance on setting up a Je-S account and on filling out the Je-S forms can be found at: https://je-s.rcuk.ac.uk/jesHandbook/jhHome.aspx.

When adding a new proposal, you should select:

Council ‘MRC’
Document type ‘Standard Proposal’
Scheme Type ‘Research Grant’
Call ‘Experimental Medicine Sept 2011’

Note that clicking ‘submit document’ on your proposal form in Je-S initially submits the proposal to your host organisation’s administration, not to MRC. Please ensure you allow sufficient time for your organisation’s submission process between submitting your proposal to them and the call closing date. MRC must receive your application by 4pm on 20 September 2011.

Full details on how to apply to this Call through Je-S are available here.

Please note that this call-specific guidance should be followed in place of the generic proposal guidance available in Je-S.

Contacts

The Head Office Programme Manager for this scheme is Dr Gavin Malloch mailto:gavin.malloch@headoffice.mrc.ac.uk

The MRC Translational Scientist in Mental Health is Dr Jayne Bailey. Jayne’s role is to disseminate MRC's plans in this area and help in the forging of collaborations. Jayne can be contacted at (Jayne.Bailey@headoffice.mrc.ac.uk)

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