Joint Global Health Trials (JGHT) Call 11 – outline stage
This scheme seeks to support research that addresses the health problems affecting low and middle income countries (LMICs) by funding definitive trials that are likely to produce implementable and generalisable results to change policy and practice.
- LMIC Principle Investigators may be based at higher education institutions or non-profit research institutions.
- UK Principle Investigators must be based at eligible UK research organisations.
- Applications must include investigators based in the country/ies where the trial will take place.
- Trials can be up to five years duration.
Please note: if your proposed research relates to Covid-19, please see ‘additional information' section below for links to other relevant funding opportunities.
|Opening date*||May 2020|
|Deadline for Outline proposal||08/10/2020||16:00 GMT|
|Decision on Outline proposal||December 2020|
|Invited full application deadline||25/02/2021||16:00 GMT|
|Final decisions||June 2021|
Where the research can take place
Studies funded through this scheme should be based in countries with low or middle income economies, excluding the exceptions listed below. World Bank definitions of low and middle income economies can be found at DAC List of ODA Recipients.
Exceptions: please note that from 2020/21 our partnerships with China and India have a renewed focus: applications involving China or India must have global or regional development impact as the primary objective, with local or national impacts within China or India as secondary objectives.
Who can apply
This call is open to and particularly encourages applicants to apply from eligible research institutions based in low- and middle-income countries (LMICs) as well as the UK.
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. Academic-industry collaborations will be considered under the MRC Industry Collaboration Agreement (MICA) mechanism - please see the MRC MICA web page for more information.
This scheme is open to Principal Investigators who are employed by eligible research institutions based in LMICs where the work will take place and to Principal Investigators who are employed by an eligible UK institution.
Applicants based in China or India are not eligible to be the Principal Investigator of an application to this call but are welcomed as international Co-Investigators within proposals.
Eligible UK institutions include UK Higher Education Institutions, Research Council institutes, and eligible Independent Research Organisations (IROs). Further detail can be found on the UKRI eligibility web page.
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 and on-going monitoring.
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 a Principal Investigator on more than two proposals submitted to this call.
Co-applicants and collaborators
The nature of this scheme means that we would expect applicants to be predominantly based in LMICs. 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 LMIC where the trial will be conducted. Investigators employed by an institution in China, India or a high-income country outside the UK cannot be a Principal Investigator on a proposal but can be a Co-Investigator and are expected to make a significant contribution to their own research costs, including covering their own overheads.
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 Management of Global Health 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. Please note that ethics approval should be obtained from a UK ethics committee as well as in any countries hosting the trial.
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 JGHT@mrc.ukri.org.
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 (LMICs). The scheme is focused on late-stage clinical and health intervention trials evaluating efficacy and effectiveness.
Call 11 specifically invites applications for definitive randomised controlled trials (RCTs) that provide generalisable data, beyond a single country or setting. The evidence generated should be robust and relevant to international and regional policy makers and directly answer questions to change policy and guidance.
Priorities for this call
Trials should address the major causes of mortality or morbidity in LMICs, particularly those that affect the most vulnerable populations.
The scheme will give priority to proposals for definitive trials that are likely to produce implementable and generalisable results to change policy and practice. Stakeholders, such as policy makers, should be engaged throughout the research process in order to ensure trial results are implementable, scalable and in line with policy needs. All applications must include investigators/partners based in the country/ies where the trial will take place.
We are open to funding a smaller number of more ambitious trials than in previous years.
The joint global health trials scheme funds RCTs, although nested studies and other types of methodologies can be used alongside RCTs to explore implementation and operational issues.
The scheme focuses on late-stage (equivalent to phase 3/4) clinical and health intervention trials that evaluate efficacy and effectiveness.
We encourage applications using adaptive trials designs and other innovative methodologies, where this is required to achieve the objectives of the evaluation. 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.
If there are outstanding questions on the trial design, we recommend that you consider applying for a smaller trial development grant first. This call launches on 8 September 2020, see ‘additional details’ section below for more information.
Although the breadth of the scheme is deliberately wide, we particularly welcome proposals for research addressing the coexistence of two or more chronic conditions in the same individual as well as more broadly addressing chronic non- communicable diseases, including mental health, reproductive, maternal and new born health.
The scheme encourages the evaluation of a wide range of intervention types including, but not limited to:
- behavioural interventions
- psychological therapies
- disease management
- hygiene interventions
- diagnostic strategies.
Issues to consider which would strengthen your proposal
- As the primary objective of this scheme is to develop and evaluate interventions with the potential for a significant impact on population health, applicants are encouraged to engage with local stakeholders and government and demonstrate buy-in where possible (for example through letters of support).
- Applicants are encouraged to include social science and health economics expertise to ensure that the interventions are appropriate, acceptable and feasible to their target populations and that any potential social, cultural and economic barriers to implementation are examined.
- Applicants should consider how the intervention could be implemented at scale. Where relevant, applicants should include implementation research in their proposals to provide lessons relevant to future scale-up.
- Proposed trials should, as far as it is practicable, be fully developed and costed before they are allowed to start. Applications for full trials that require preliminary data should consider applying for a trial development grant first, see ‘additional details’ section below for more information.
A total of up to £20 million is available for this call from the UK Department for International Development (DFID), the UK Medical Research Council (MRC), the National Institute for Health Research (NIHR) and Wellcome. The funders welcome trial proposals costed appropriately to provide definitive results. Around £1 million of the total budget is expected to be spent on several trial development grants.
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
- trial registration costs.
UK research will be funded at 74% of the Full Economic Cost (FEC). Research incurred by overseas Research Organisation and investigators is eligible to be funded at 100% of FEC.
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.
How to apply
Applications will be submitted to and processed by MRC on behalf of the four partner agencies.
This call has a two stage application process: an obligatory outline stage and a full stage. Decisions for invitation to the full stage are expected in December 2020 with funding decisions expected in June 2021.
Please see the call specific guidance document for detailed information on how to apply. Applications which do not follow the guidance set out in this document may be rejected.
When applying select:
- council: MRC
- document type: Outline Proposal
- scheme: MRC Jointly Funded Initiatives Outline
- call/type/mode: MRC NIHR DfID Wellcome Global Health Trials Call 11 - Outline Oct 2020.
How we will assess your application
Applications will be considered by an expert panel convened specifically for this scheme jointly agreed by Medical Research Council, Department for International Development, Wellcome and National Institute Health Research. Additional scientific experts will 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 application as there will not be an opportunity to add additional information after submission.
All enquiries should be directed in the first instance to the MRC: JGHT@mrc.ukri.org
Opportunities for Covid-19 related trials
Global Effort on COVID-19 Health Research is a new cross UK government funding call aiming to support applied health research that will address COVID-19 knowledge gaps. The focus is on understanding the pandemic and mitigating its health impacts in LMIC contexts. The call prioritises epidemiology, clinical management, infection control and health system responses.
The COVID-19 Therapeutics Accelerator is a collaborative effort to research, develop and bring effective treatments to market quickly and accessibly. You can email the Therapeutics Accelerator for more information and to share your ideas.
Trial development grant funding
The scheme remains primarily a mechanism to support definitive 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, definitive trial can be designed. Examples of work that a trial development grant can cover are:
- studies to generate specific data that are 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 for example in a cluster randomised trial, and how that contamination might be handled
- work to inform the design of the trial intervention, for instance feasibility and acceptability issues in a public health intervention, and pre- trial simulations
- 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 as drug discovery research, preclinical and early phase 1 and 2 clinical studies are ineligible for funding through this scheme. However, it would 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.
The trial development grant route requires a single application step (there is no outline stage). The call will be launched in October 2020 and call specific guidance provided. Please note, trial development grant applications are expected to be up to two years duration and up to £200k. Around £1 million of the budget is expected to support multiple trial development grants.
Together we will fund up to £20 million for the 11th round launched under the Joint Global Health Trials partnership.
Terms and conditions
Funded grants will be managed according to UKRI’s standard terms and conditions. In addition, DfID, MRC, Wellcome and NIHR require that all trials funded by this scheme are run according to the MRC guidelines for management of global health trials.
Other funding opportunities open to low- and middle-income country applicants:
- MRC Complex Interventions Guidance
- MRC Ethics Guide: Research involving human participants in developing societies
- MRC Open research data: clinical trials and public health interventions
- MRC Policies and Guidance for Researchers
- NIHR Clinical Trials Toolkit
- Wellcome Research Involving Human Participants
- Joint Global Health Trials