Stratified Medicine - Call for proposals for disease-focused partnerships to stratify disease for patient benefit
Stratified medicine is a priority area for MRC. We will commit £60m to this area over the next four years. Researchers are now invited to submit outline proposals for funding for the development of disease-focussed consortia to stratify disease.
- Aim of the Call
- Funding available
- Disease area
- Call Process
- Potential Outcomes
- Consortium Development
- Who can apply?
- How to apply
- Assessment Process
- Key Dates
- Contacts and further details
Patient response to drug treatments and therapeutic interventions varies markedly across the population as a result of differing underlying mechanisms of disease and patient responses to both disease and treatment. Stratified medicine can be described as identifying the different strata within a disease and the deeper understanding of the mechanisms underpinning these strata. Stratification will allow targeting of treatments to specific disease pathways, identification of treatments effective for particular groups of patients, and co-development of diagnostics to ensure the right patient gets the right treatment at the right time. Following consultations with a range of stakeholders, the MRC is taking a disease-focussed approach to stratified medicine.
This call sets out to develop UK-wide research consortia that are each focussed on a specific disease area, in order to stratify that disease and develop a deeper understanding of the mechanisms underpinning the stratification. Initially, priority will be given to proposals that focus on diseases where an existing therapy exists as a tool for stratification. The consortia must build upon existing scientific and clinical expertise; clinical research infrastructure such as that provided by National Institute of Health Research, Scottish Government Health Directorates, The National Institute for Social Care and Health Research, Welsh Government and Health, Social Services and Public Safety, Northern Ireland; and have significant links with industrial partners. Each consortium should provide a dynamic platform for research that will create future opportunities for further funding and collaboration.
MRC has allocated up to £60m over 4 years to fund consortia up to 5 years duration. It is likely that this will be split as £15m commitment per year for four years, although this is dependent on the quality of proposals received each year.
The MRC has not pre-specified priority disease areas. Instead, applicants are invited to submit outline applications that clearly describe and justify why a particular disease area is ripe for stratified approach. This justification should clearly articulate:
- Existing knowledge of failure of certain groups to respond to therapeutic intervention; and
- Clinical insight into potential strata linked to molecular and / or phenotypic analyses; and
- Increased knowledge of these strata would be expected to have a positive effect on clinical outcomes.
Some evidence of economic benefit derived by stratification should also be included, but MRC does not expect full health economic studies at this stage.
Given the extensive work being carried out by Cancer Research UK in the stratified medicine of cancer, this initiative is only open to non-malignant diseases.
The call process will be in three stages:
- Outline Application
- Consortia development
- Full Application
To enter the first stage of the competition, you must first submit an outline application via Je-S, answering all mandatory sections. The following guidance will walk you through completing the Outline Application Form, case for support, and the Je-S submission. Outlines must be received by MRC by 4pm on 24th January 2012. Successful outline applicants will then be invited to submit a full application.
The purpose of the outline application is to ascertain the following:
- Clear and compelling evidence for the basis for stratification in this disease
- Compelling scientific rationale for the proposed work to delineate strata and potential or proposed utilisation of the strata
- Evidence of strong partnership working with academic groups, clinical research infrastructure and industrial partners or Evidence of plans to build these networks in preparation for a full submission in the next round of funding.
- Robust management and governance
- Track record of the partners individually and, if appropriate, as collaborators
- The case for large scale investment in this consortium
Outline Case for Support
Applicants should complete the Outline case for support as described below and then submit this as a PDF to your Je-S application. The outline case for support must be no more than 4 pages including references using Arial 11pt typeface. Applicants must use the following headings:
This title should be the same as the project title of your Je-S submission.
Summary of the project
Investigators and Partnerships
- Details of lead applicant, track record of research and/or funding
- Details of co-applicants, track record of research and/or funding
- Details of collaborators
- Evidence of successful partnership working - for success, there will need to be true collaborations between academic researchers together with clinicians and commercial sector. Please provide letters of support from existing or potential partners at this stage.
- Evidence that existing strength in collaboration or proposed collaboration will deliver outcomes.
- Teams and capabilities e.g. cohorts, infrastructure that will contribute to the project.
- Justification of disease area in accordance with criteria stated above.
Plan of Research
- Outline your scientific plans to identify disease strata
- Outline scientific plans to use this stratification for deeper investigation
- Identify the infrastructure you will use to achieve your aims e.g. clinical research, sequencing hubs, patient cohorts etc.
- How will you deliver these plans in a clinical setting
- Outline your plans to develop and/or manage clinical cohorts, samples and data in accordance with MRC’s open access policies
- What is the innovative/creative methodology development or application to demonstrate the impact of this stratification?
- Brief economic support that stratification will be beneficial in this disease.
- What are the expected outcomes by 2014 and by programme end
Management and Governance
- Outline the consortium management – how will industry and clinical research be involved?
Full applications should follow the standard MRC research grant application form and headings. Collaborative research proposals between academics and industry partners are strongly encouraged, all applicants are advised to refer to the guidance on MRC Industrial Collaboration Agreements (MICA) and must submit a MICA form with their application.
Guidance for the full application will be made available to successful Outline applicants.
There will be three likely outcomes:
- Outline proposal successful – applicants will be invited to develop a full proposal to be submitted 28th June 2012
- Outline proposal unsuccessful – applicants will not be allowed to submit at this or further rounds
- Outline proposal deferred – some elements of the application are strong but other areas need developing. The applicants will be given time to develop the consortium further and invited to submit for the following round.
It is likely that different disease areas will be at different stages of stratification and development, with research into some diseases ready for substantive investment while others may need more development time. Please indicate the stage of development of your consortium and whether further development will be required through workshops, etc – if so specify the proposed content of the workshop and funding required. Note these costs should be included in your total costs within the JeS proposal, but clearly highlighted in your case for support.
There will be further rounds of funding through this initiative and this will allow other disease areas to be developed for future rounds. Funding can be allocated in this first round to support development of consortia for future rounds.
Please include estimates of costs you anticipate will be required for developing and running the consortium. This total must also be entered on the main JeS form. The Je-S system form will calculate the expected total project duration, cost and estimate the MRC contribution, based on 80% of the requested costs.
This call follows standard RCUK eligibility criteria and is open to UK-based researchers who can show 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 web page are eligible to apply.
Research proposals that are led by commercial entities are not eligible. However applications may include collaborations with commercial parties under the relevant agreements. These will be considered by MRC as industry collaborative research proposals.
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. 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.
A list of frequently asked questions is available here.
When adding a new proposal to Je-S, you should select:
- Select New Document
- Under ‘Select Council’ select MRC
- Under ‘Select Document Type’ select Outline Proposal
- Under ‘Select Scheme’ select Standard Outline
- Under ‘Call Type’ select “Stratified Medicine”
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 24th January 2012.
This call will be overseen by a Steering Group (SG) chaired by Professor Patrick Johnson (Queen’s University Belfast, Chair of the MRC Translational Research Group) and comprised of senior independent academics, and industry representatives. The outline applications will be assessed and shortlisted, according to the criteria stated above, by an expert scientific panel seeking additional advice if necessary.
Full proposals will be sent out for international peer review and then assessed by the expert scientific panel. This will involve an interview stage for the shortlisted candidates, likely to be in October 2012. This panel will make the final funding decisions.
The Je-S system will be accepting outline applications from 6th December 2011
The closing date for outline applications is 24th January 2012
Deadline for full applications is 28th June 2012
Final Panel meeting will take place in October 2012
If you have any scientific queries please contact:
Dr Des Walsh
0207 395 2239
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
Telephone: +44 (0) 1793 44 4164