Joint Global Health Trials scheme – launch of sixth call for proposals
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Joint Global Health Trials scheme – launch of sixth call for proposals
The UK Department for International Development, the Medical Research Council and the Wellcome Trust are pleased to jointly announce the launch of the sixth call for proposals under this initiative to fund global health trials.
DfID, MRC and the Wellcome Trust each have a strong history of supporting research that aims to improve health in low and middle income countries. The three partner agencies share the view that in order to have maximum impact on health we need to work together to provide evidence of the best, and most appropriate interventions. Pooling resources brings the necessary funds and experience together to achieve implementable results which address health problems affecting low and middle income countries. Together we will invest up to a total of £20 million for the sixth call to be launched under the joint global health trials partnership.
Objectives and remit
The purpose of this scheme is to provide funding for the best proposals to generate new knowledge about interventions that will contribute to the improvement of health in low and middle income countries.
The programme will give priority to proposals that are likely to produce implementable results and that are designed to address the major causes of mortality or morbidity in low and middle income countries.
The scheme is open to the best proposals which address any major health related problem affecting low and middle income countries, particularly those that affect the most vulnerable populations. Although the breadth of the scheme is deliberately wide, we particularly welcome proposals for research into chronic non-communicable diseases, in recognition of the increasing burden of these conditions in low and middle income countries. We also welcome innovative proposals which address reproductive, maternal and new born health.
The scope of the scheme encompasses interventions of all kinds, including, but not limited to, behavioural interventions, complex interventions, disease management, drugs, vaccines, hygiene and diagnostic strategies.
This scheme is primarily focused on late stage (equivalent to phase III/IV*) clinical and health intervention trials evaluating efficacy and effectiveness. *Please note that this scheme will not include support for registration of pharmaceutical products.
The scheme aims to fund research which is rigorous, has robust methodologies and will provide clear, definitive, implementable evidence addressing questions of major importance to mortality and morbidity. The scheme primarily funds RCTs, but innovative trial methodologies and adaptive designs are also welcome. In all instances a clear justification for the chosen methodology must be provided and a clear reason for why the chosen trial design is likely to provide the most robust evidence to address the research question
Phase IIb trials of major relevance to the objectives of this scheme may be permitted. If you are considering submitting a phase IIb trial, please consult one of the partner agencies involved for further guidance.
Issues to consider which would strengthen your proposal:
- It is important that the results of research funded under this scheme are implementable; we therefore encourage applicants to include, where relevant, health systems, economics and operational research in their proposals to provide lessons relevant to scale-up.
- Proposers are encouraged to include social science and health economics expertise to ensure that the interventions are appropriate, acceptable and applicable to their target populations and that the social, cultural and economic barriers to uptake are examined.
- Strong partnership links with institutions and policy makers in low and middle income countries will be important to the long-term impact of the research funded. This should be considered when applicants are preparing their consortia.
- Proposed trials should, as far as it is practicable, be fully developed and costed before they are allowed to start. Progress will be monitored throughout the lifetime of the trial.
- One objective of this scheme is to promote interventions with a significant potential impact. Therefore, we invite the applicants to comment on the broader applicability of the intervention, if appropriate.
Support is conditional on the host institution being able to demonstrate that they are able to conduct the trial to the standards set out in the MRC guidelines for good clinical practice in clinical trials.
Under this scheme it is expected that the host institute will be the sponsor of the trial. Support will be conditional on all required ethical, legal and regulatory approvals being obtained before the trial commences.
The scheme is targeted at trials led by academic groups, and not at trials led by commercial companies or product development partnerships (PDPs). However, applications are welcome from investigators from academic institutions who wish to collaborate with commercial companies or PDPs.
Geographical scope: Studies funded through this scheme should be based in countries with low or middle income economies. World Bank definitions of low and middle income economies can be found at the following webpage: http://data.worldbank.org/about/country-classifications
Preference at the evaluation stage will be given to studies based in low and middle income countries in the following regions: Sub-Saharan Africa, South Asia and East Asia and the Pacific. The scheme also encourages Principal Investigators from these regions.
The geographical scope of the call is flexible but in all instances the choice of location and relevance to the problems considered should be addressed in the proposal.
Funding for preliminary studies
In addition to full applications in this call we will also be offering a second application type: trial development grants.
The scheme remains primarily a mechanism to support full trials. However, we recognise that preliminary work is often needed in order for applicants to develop innovative partnerships and trial proposals.
The aims of a trial development grant must be to address questions which need to be answered before a credible, competitive, full trial can be designed. Examples of work that a development grant can cover are:
- Studies to generate specific data that is needed to inform the trial design, such as to determine the sample size, outcome measures, recruitment strategy, follow-up strategy, appropriate monitoring activities and timings. Work to understand the likelihood of contamination within the trial e.g. in a cluster randomised trial, and how that contamination might be handled.
- Work to inform design of the trial intervention, for instance feasibility and acceptability issues in a public health intervention.
- Trial development grant funding cannot be used in this scheme for drug, vaccine, device, diagnostic or other biomedical intervention development. This means that activities such drug discovery research, preclinical and early phase 1 and 2 clinical studies are ineligible for funding through this route. However, it may be appropriate to use a trial development grant to address trial feasibility questions such as the best way to provide a particular drug within a specific context or population.
Trial development grant holders will not be automatically awarded funds for a full trial upon completion of their development grant. If the Joint global health trials partnership is still live by that point, they could submit an outline proposal to the main trial application route in open competition with all other applicants. If the partnership is not live anymore, potential applicants will need to investigate other potential funding sources either with the three funders for the current joint initiative or elsewhere.
How to apply?
Applications will be submitted to and processed by MRC on behalf of the three partner agencies.
There are two application types:
1. Outline proposals for a global health trial research grant (two stage application process)
2. Trial development grant proposals (one stage application process)
Please see the Guidance document (link) for further information on applying through either route.
The MRC must receive your outline proposal by 16:00 British Summer Time on Thursday 10th September 2015.
A total of up to £20 million is available. This is expected to fund several Global Health trial research grant awards. Depending on the range of proposals received, around £1.5 million of this amount is expected to be spent on trial development grants, and this amount is also expected fund several awards.
To be successful trial proposals do not need to be large-multi-centre trials. One of the evaluation questions will be whether the proposed scale of the research is necessary and cost-effective for answering the research question.
You may request support for:
- All research costs that are attributable to the trial. For example, appropriate percentages of the investigators’ time, scientific, technical and administrative staff including statisticians, research nurses, trial managers etc., consumables, items of equipment, data /sample handling and archiving and travel.
- The cost of holding trial steering and data monitoring committees.
- Training and support for a trial manager.
Regulation, ethical review and liability may vary across different countries. Principal Investigators and proposed sponsors should ensure that they have adequately understood the feasibility and costs of participation of proposed international centres. For example, insurance arrangements will vary between countries and the sponsor (usually the host institution) is responsible for ensuring adequate arrangements are in place at each site.
This scheme is open to Principal Investigators who are employed by eligible institutions based in low or middle income economies where the research work will take place and to Principal Investigators who are employed by an eligible UK institution. Eligible UK institutions include UK Higher Education Institutions, Research Council institutes, and eligible Independent Research Organisations (IROs). All IROs listed on the Research Councils UK web page: www.rcuk.ac.uk
For researchers based in low or middle income economies, eligible institutions include higher education institutions and non-profit research institutions. If the application is submitted by an LMIC organisation, the primary headquarters of that organisation must be in one of the LMIC countries where the trial will take place. This means that the institution sponsoring a PI must be legally registered in the UK or in a LMIC and the PI must be employed by the institution that is hosting the research.
Research Institutions based outside the UK will be asked to complete additional eligibility and financial checks before an award is offered, and awards will be dependent on satisfactory completion of those checks.
MRC units and institutes can apply to this call; usual rules for funding grants to MRC units and institutes will apply. If you are based at an MRC unit or institute please contact your local MRC research support office for further information.
It is not permitted for the same person to be Prinicipal Investigator on any more than two proposals submitted to this call.
Co-applicants and collaborators
The nature of this scheme means that we would expect applications to be predominantly based in low or middle income countries. Funding for co-applicants and collaborators in other regions can be requested, but we would expect that the majority of funds would support the costs in the low or middle income country where the trial will be conducted. Investigators employed by an institution in a High income economy country outside the UK cannot be a Principal Investigator on a proposal, but can be a Co-investigator.
We are not able to accept resubmissions of proposals that have already been considered under this scheme. If you have substantially changed a previous proposal and wish to discuss whether it might be eligible, please contact email@example.com.
Applications will be considered by an expert panel convened specifically for this scheme jointly agreed by MRC, DFID and the Wellcome Trust. Additional scientific experts might be invited to provide written comments if the funders and/or panel chair deem this necessary.
The panel’s decision will be final and will not be open to appeal Please ensure that all necessary information is incorporated in your outline proposal as there will not be an opportunity to add additional information after submission.
Terms and conditions
Funded grants will be managed according to MRC’s standard Terms and conditions
DfID, MRC and the Wellcome Trust require that all trials funded by this scheme are run according to the MRC guidelines for good clinical practice in clinical trials.
Please also see the Wellcome Trust guidelines on research involving people living in developing countries www.wellcome.ac.uk
The deadline for submission of outline applications is 4pm BST on 10 September 2015. We intend to inform applicants in late November 2015 whether they are invited to submit a full proposal. The deadline for full proposals is likely to be in February 2016, with final decisions likely to be available in June 2016.
Contacts and guidance
- Guidelines for Good Clinical Practice in Clinical Trials
- Clinical trials toolkit
- Research involving human participants in developing societies
- MRC ethics and research guidance policies
All enquiries should be directed in the first instance to the Medical Research Council: Mandy.firstname.lastname@example.org