Stratified Medicine Initiative call for proposals – disease-focused partnerships to stratify for patient benefit
Stratified Medicine is a priority area for the MRC. We currently have significant investment in this area of research. Researchers are now invited to submit outline proposals for funding for the development of further disease-focussed consortia to stratify disease.
The Stratified Medicine Initiative forms a major part of the MRC’s research strategy. The overall aim is the discovery and understanding of disease subtypes. Whether described as stratified, precision or personalised medicine, the research will provide new insights into disease mechanisms, that will enable better tailoring of existing treatments, and pave the way for the development of new treatments, diagnostics and care pathways.
Through this Initiative we currently support thirteen consortia, in disease areas of high industry interest and/or scientific potential. Together the supported consortia have attracted over forty small, medium and large companies from across the UK and internationally and are partnered with thirty-four universities. Each consortium is a scientific discovery engine with a finely characterised patient population at its heart contributing to a deeper understanding of disease process as well as trialling new and existing treatments in stratified groups for real patient benefit.
This call aims to support consortia to address disease areas where there is a strong case for scientific advancement and major unmet clinical need.
For this call we will maintain stratification by response to treatment but broaden the scope to include stratification by risk, diagnosis and/or prognosis. For example, proposals could focus on:
- diseases with no existing treatment but a strong case for clinically important strata (e.g dementia) or
- earlier disease states in which assessment of why some patients are more resilient than others to the onset and progression of disease. Whatever the stratification strategy employed, they should open up new therapeutic strategies and mechanistic understanding. Please note that this does not imply prevention studies.
The consortia must:
- Build upon existing scientific and clinical expertise.
- Utilise clinical research infrastructure, such as that provided by the National Institute of Health Research, Scottish Government Health Directorates, National Institute for Social Care and Health Research, Welsh Government and Health, Social Services and Public Safety, Northern Ireland.
- Forge significant links with industrial partners.
Each consortium should provide a dynamic platform for research that will create future opportunities for further funding and collaboration.
A successful consortium must also address a number of key challenges presented by stratification such as methodology and study design, data handling, integration, and analysis, inclusion of potential new therapies, and application of clinical pharmacology. Furthermore, patient involvement is strongly encouraged at all stages of your application. You will need to have a comprehensive patient and engagement programme within your full proposal. You will also need to develop a strong consortium management programme.
Up to £15m to fund consortia up to 5 years in duration will be available. There will be an opportunity for the MRC to leverage additional co-funding from potential funding partners, including Arthritis Research UK (ARUK), British Hearth Foundation (BHF), and Cancer Research UK (CRUK) for appropriate studies.
Applicants are invited to submit outline applications that clearly describe and justify why a particular disease area is likely to contribute important understanding of disease, whether employing stratification by response to treatment or by risk, diagnosis and/or prognosis. This justification should clearly articulate:
- existing knowledge of failure of certain groups to respond to therapeutic intervention, or
- existing evidence of the potential to distinguish clinically important subgroups by means other than response to therapeutic intervention (e.g. rate of progression of disease)
- clinical insight into potential strata linked to molecular and / or phenotypic analyses
- opportunities for major advance in mechanistic understanding
- increased knowledge of these strata would be expected to have a positive effect on clinical outcomes
- potential value to future industry Research and Development
Some evidence of economic benefit derived by stratification should also be included, but the MRC does not expect full health economic studies within the proposal.
Applications from any disease area are welcomed, and will be considered in open competition. The MRC has a strong focus on inflammatory diseases in the existing portfolio, and welcomes further diversification of the portfolio, but also recognising that there may be potential to capitalise on existing investments. For illustrative purposes only, diversification of the portfolio might include diseases important from a Global Health perspective (addressing the needs of low and middle income countries), complex childhood diseases (where disease appears in childhood and has several underlying disease mechanisms), cancer, especially cancer immunotherapies, and pain.
The call process will be in three stages:
1. Outline application
To enter the first stage of the competition, you must submit an outline application to MRC via Je-S by 4pm on 1st December 2016. You must answer all mandatory sections and attach a completed Outline Stratified Medicine Case for Support form, Gantt chart and supporting documents (see Guidance for Outline Stage Stratified Medicine Consortium Applicants for details).
The purpose of the outline application is to ascertain the following:
Scientific potential and tractability:
- Is there a compelling rationale or a priori for large scale investment to understand disease subtypes in this area?
- Does the proposed consortium clearly describe the vision and science underpinning it?
- Does it employ a stratification strategy focused on identifying groups of patients with distinct endotypes?
- Does it clearly present and test a molecular mechanism(s), or hypothesis, that is able to account for the observed differences in endotype(s)?
- Does it provide proof of concept data supporting the hypothesis to be tested and the approach being taken?
- Is there potential for the research to stimulate future industry Research and Development or provide other value to industry.
- Is it challenging while being realistic in terms of content?
Quality of the consortium:
- Does it seek to establish a dynamic research platform able to respond to internal and external scientific developments?
- Does it present a set of synergistic work packages and governance structure able to provide a balanced portfolio of short and longer term outputs, which can provide a range of partnering opportunities?
- Does the consortium have an appropriate strategy to address the data management, data analysis and methodological challenges that it is likely to face?
- Is there evidence of strong partnerships working with academic groups, clinical research infrastructure, patients and industrial partners or evidence of plans to build these networks in preparation for a full submission?; and
- In light of all of the above, is there a strong case for large scale investment in this consortium?
Note that clicking ‘submit document’ on your proposal form in Je-S initially submits the proposal to your host organisation’s administration, not to the 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 1st December 2016.
2. Consortia development
Successful outline applicants will be invited to attend a voluntary MRC workshop on 28th February 2017, the purpose of which is to assist in developing high quality full applications. Whilst not compulsory, applicants are strongly encouraged to attend. Following this, each PI will be provided with small seed funding (up to £15k) to enable them to:
- Hold consortia building workshops/meetings to further engage with potential partners and define consortium goals
- Assist with consortium planning
The type of consortia we are seeking to support pose significant and novel coordination challenges that require careful project planning and management. To help ensure that consortia are well placed to address these challenges, we expect that some of the seed funding will be used to access appropriate project management expertise, to assist in the preparation of the full application.
3. Full application
Full application should be submitted via Je-S by 4pm on 22nd June 2017. As with the outline application stage, full stage applicants will be required to complete a bespoke case for support form. Guidance on how to complete this form and make the full submission will be provided to successful Outline applicants.
Collaborative research proposals between academics and industry partners are strongly encouraged and all applicants are advised to refer to the guidance on MRC Industrial Collaboration Awards (MICA) and must submit a MICA form with their application. We strongly recommend that you and your potential industrial partners refer to the MICA guidance, so that all parties are aware of the MICA options and requirements. You should contact your Technology Transfer Office to assist you with this process.
This call follows standard RCUK eligibility criteria and is open to UK-based researchers who can show that they will direct the proposed research and be actively engaged in carrying it through. Eligible institutions include UK higher education institutions, Research Council Units and Institutes, and eligible Independent Research Organisations (IROs). All IROs listed on the RCUK website are eligible to apply.
Research proposals that are led by commercial entities are not eligible.
This call will be overseen by the MRC Stratified Medicine Group chaired by Dr John Stageman (Bionow and University of Manchester) and comprised of senior academics and industry representatives. The outline applications will be assessed and shortlisted, according to the criteria stated above, by an expert review panel seeking additional advice if necessary. This meeting will be held on 6th February 2017.
Full proposals will be sent out for international peer review and then assessed by the expert review panel. This will involve an interview stage for the shortlisted candidates, on 2nd November 2017. This panel will make the final funding decisions.
|Call launch||21st July 2016|
|Je-S open for outline applications||30th August 2016|
|Closing date for outline applications||4pm, 1st December 2016|
|Outline applications assessed||6th February 2017|
|MRC Workshop for successful outline applicants||28th February 2017|
|Closing date for full applications||4pm, 22nd June 2017|
|Full applications assessed, including interview||2nd November 2017|
If you have any scientific queries please contact:
Dr Rosie Fryer
0207 395 2246
For queries regarding preparation and submission of your application, in the first instance please refer to all documentation relating to the scheme, particularly the Je-S Help which will guide you through the standard processes for preparing a proposal and costing your proposals.
If you still have a query, contact the Je-S helpdesk:
Je-S Helpdesk: Monday–Friday 9.00am–5.00pm