Hubs for trials methodology research (HTMR)
This call is now closed for applications and is only available for reference purposes.
As part of the developing MRC - National Institute for Health Research (NIHR) strategy for health research, the MRC plans to increase support for the national methodological platform in clinical trials research. The MRC is therefore inviting proposals for Hubs in trials methodology research. Successful Hubs will provide UK-wide coverage and be networked together.
- Expectations of Hubs in trials methodology research
- Background to the call
- Process for establishing HTMRs
- Objectives and remit of this call for proposals
- Funding available
- Metrics for evaluating HTMRs once established
- Assessment criteria
- Hubs for Trials Methodology Research Panel (HTMR)
Expectations of Hubs in trials methodology research
MRC funding for a Hub will support resources to enable the establishment of a regional focus for high-quality, cutting-edge methodology research in clinical trials. Each Hub will bring together and reinforce existing strengths in methodological research as well as fostering new lines of research.
The expectation is that individual Hubs will:
- provide scientific leadership in methodology research related to the design, conduct or analysis of clinical trial studies;
- have/develop critical mass in trials methodology research;
- establish a high-quality research programme in trials methodology research;
- have effective links with regional and national clinical trials units (to ensure that the methodology research programme is influenced by real-world issues faced by triallists and to accelerate application of new methods into clinical trials);
- also provide support/advice to the local/wider clinical trials research community on methodological issues;
- establish a training programme in methodological research;
- demonstrate commitment from the host institution;
- participate and engage in the UK network of MRC-funded HTMRs.
The Hub will be managed by a director to ensure its aims and objectives are realised.
Research Hubs are intended to be joint investments by the MRC and the host institution, so a strong commitment from the Vice Chancellor (or equivalent) will be required.
A UK network of HTMRs
Individual Hubs will be networked together to further strengthen the national methodological platform for clinical trials research. The UK network of MRC funded HTMRs will facilitate information exchange about research projects and issues, enable networking and encourage cross-Hub collaborative working.
Collectively the UK network of HTMRs will facilitate and accelerate the translational process through the development of new and improved approaches for the design, conduct and analysis of clinical trials, particularly in methodologically challenging areas.
Background to the call
Under the single health research fund, the MRC and NIHR are developing an overarching strategy for health research which is due to be published early in 2008. It will contain joint MRC/NIHR plans for the following areas:
- Translational medicine research;
- Public health research;
- E-health research;
- Methodology research;
- Building up human capital.
The unified MRC and NIHR strategy in methodology research is being led by the MRC on behalf of the MRC and NIHR, and the overall joint vision is:
- To develop a high-quality national platform in methodology research across the populations health, and
- To establish the UK as a world-class leader in methodological innovation in health research.
The Hubs in trials methodology research will make a significant contribution to the delivery of this joint vision.
Details about the Methodology Research Programme, a new funding mechanism for investigator-led and commissioned research, can be found on the MRC website under the funding opportunities section.
Process for establishing HTMRs
This is a strategic initiative to strengthen UK-wide expertise in trials methodology research. It will be achieved through:
i) This call for proposals to establish research Hubs in locations other than those where there is existing MRC unit expertise and critical mass in trials methodology research.
ii) A separate initiative to enhance the capacity of MRC units with critical mass and expertise in clinical trials methodology to function as regional hubs.
Objectives and remit of this call for proposals
Successful applications will meet the expectation of Hubs (click) and may offer specific expertise in clinical areas (e.g. mental health, cancer, cardiovascular, ageing or public health) and/or trials methodology (e.g. novel trial designs, health economics, patient-based outcomes, early phase studies; complex interventions etc).
This call for proposals does not include support for project or programme funding for methodology research. Instead successful Hubs, once established, will be expected to gain funding for trials methodology research from the MRC (via the Methodology Research Programme) and other funders. Success in attracting project funding will be a key factor in considering potential future requests for renewal of funding of Hubs (metrics for evaluation of Hubs).
Funding available
Funding is available for five-year awards and the total budget for this initiative is £12m. Individual awards must not exceed £3m.
Support available
- The director’s salary costs for the portion of their time dedicated to the Hub;
- Funds to enable the Hub to function as a cohesive regional focus for clinical trials methodology research (e.g. funds for pilot studies, support posts, networking costs, common resources/datasets and equipment etc);
- Start-up costs for new positions to develop critical mass (this can include the initial costs of new appointments from overseas);
- Funds to provide a support/advisory service for triallists and clinical trials units (this role will extend beyond those directly involved in the Hub);
- Funds for training and capacity building in methodologies underpinning clinical trials research. Hubs are eligible for MSc and PhD studentships in addition to the MRC Doctoral Training Grants already given to the university. Such requests should form part of the hub application;
- Capital and refurbishment costs;
- A total of £250k for networking costs with other Hubs;
- Other resources essential to establish and maintain the research Hub;
- Public and user engagement, coordination and collaboration costs to bring the research closer to the patient or to application.
Funding for project and programme funding in trials methodology research is available through the Methodology Research Programme.
Due to the implementation of Full Economic Costing (FEC), the MRC will not provide support for any shared infrastructure or support posts which could be charged out to grants, even if they have been funded previously through research council grants.
Metrics for evaluating HTMRs once established
The expectation is that this funding will enable the Hubs to establish themselves as self-sustaining cohesive units focusing on methodology research in clinical trials. It is expected that support for new activities and facilities through the Hubs will be gained through conventional grants during the lifetime of the award. If Hubs do submit requests for renewal of MRC funding, the expectation is that this will be at a substantially reduced level. Metrics against which the new application will be assessed will include:
- Quality and critical mass of expertise offered by the Hub in specific therapeutic and methodological areas;
- Quality of the Hub’s research programme;
- Successful and effective support to wider clinical trials community;
- Successful training programme;
- Effective contribution to the HTMR network as a whole and involvement in cross-Hub initiatives;
- Added value provided by the Hub.
Assessment criteria
Shortlisting assessment criteria
- Would the proposed Hub constitute a regional hub for excellence in clinical trials methodology research and training?
- Will the Hub (develop) provide critical mass and high-quality trials methodology expertise?
- Does it have effective links with clinical trials units?
- Are the applicants willing to provide a methodological advice/support role to the wider trials community?
- Are the applicants willing to support a training programme in the methodological disciplines associated with clinical trials research?
- Is there adequate geographical spread in those proposals shortlisted to go forward to the funding panel meeting?
Assessment criteria for funding:
Overall
- Is there adequate geographical spread in those proposals prioritised for funding?
- Are the aims and objective of the HTMRs realistic and achievable?
- Are the key components in place (or planned to be in place) to deliver the overall objectives of the Hub?
- Are the proposed metrics for this specific Hub proposal appropriate?
Proposed Hub as a focus for clinical trials methodology research?
- Would the proposed Hub constitute a regional hub for excellence in clinical trials methodology research and training?
- Does the proposal bring together a critical mass of researchers in trials methodology and clinical trials research?
- Does the proposed grouping have clear areas of methodology research and/or clinical expertise – are these areas with particular methodological needs or for which there is limited existing national expertise?
- Does the proposed grouping have effective links with clinical trials units (both locally and nationally)?
- Are there satisfactory arrangements in place to ensure that the Hub will operate as a cohesive research centre, encouraging networking and interaction and enabling individual members to come together share to issues and research ideas?
Provision of a methodological advice/support role to the wider trials community
- Do the proposals include adequate and appropriate plans to provide a methodological advice/support role to the local trials community – this should include both local and national enquiries?
Training programme
- Does the proposed training programme meet capacity building needs in trials methodology research?
- Are the management plans to establish and develop a training programme adequate?
Management arrangements
- Will the proposed management arrangements deliver the Hub’s aims and objectives?
- Does the director have the appropriate skills and experience to deliver the Hub’s aims and objectives?
- Is there an appropriate management and governance structure for the Hub and its members?
Research environment and host institution commitment
- Does the proposed Hub build on and add value to existing related research and other activities?
- Has the host institution demonstrated a commitment to supporting the Hub?
Justification of resources requested
- Have the applicants clearly set out the reasons for requesting the level of staffing and overall resources? Is this level adequate for the work described?
- Taking into account the expected benefits of the work proposed and the level of resources requested, do the proposals promise good value for money?
Ethics and governance arrangements
- Are appropriate ethics and governance arrangements in place for research undertaken by the Hub?
Exploitation (commercial and in the public sector) of research undertaken by the Hub
- What plans does the Hub have to ensure that its developments in research methodology are disseminated and communicated to the wider clinical trials community?
Public engagement
- Are effective arrangements in place to promote public engagement in the Hub’s activities?
Hubs for Trials Methodology Research Panel (HTMR)
- Professor Nick Wareham, MRC Epidemiology Unit, Institute of Metabolic Science;
- Professor Deborah Ashby, Wolfson Institute of Preventative Medicine Queen Mary, University of London;
- Professor Mark Buyse, International Institute for Drug Development;
- Professor John Cairns, Department of Health Economics;
- Professor Ray Fitzpatrick, Department of Public Health, Nuffield College;
- Professor Mark Levine, Henderson Research Centre;
- Professor Tim Peters, Department of Community Based Medicine and Research, University of Bristol;
- Professor Simon Thompson, MRC Biostatistics Unit, Institute of Public Health;
- Dr David Wright, Medicines and Healthcare Products Regulatory Agency (MHRA);
- Professor Maria Grazia Valsecchi, University of Milan.