Joint Global Health Trials

Call 11 – trial development grants

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 principal investigators may be based at higher education institutions or non-profit research institutions.
  • UK principal investigators must be based at eligible UK research organisations.
  • applications must include investigators based in the country/ies where the trial will take place.

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.

Applicants working in India and/or China who wish to apply are strongly advised to contact the office for guidance as early as possible.

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.

Principal investigators

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.

For researchers based in LMICs, 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 Principal Investigator must be legally registered in the UK or in a LMIC and the Principal Investigator 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 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.

Institutional support

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.

Resubmissions

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.

Objective

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.

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 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 e.g. 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.

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 individual funders who fund the Joint Global Health Trials scheme, or elsewhere.

Intervention type

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
  • drugs
  • vaccines
  • 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, trial development grants can be used to engage with relevant stakeholders and government to build credible links and enable the demonstration of buy-in for the future trial.
  • 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 explore implementation research questions for inclusion in trial development grant or future trial to provide lessons relevant to future scale-up.

Funding available

A total of up to £1 million is available for this call to support several trial development grants from the Foreign, Commonwealth and Development Office (FCDO), the UK Medical Research Council (MRC), the National Institute for Health Research (NIHR) and Wellcome. A further £19 million has been allocated to Research Grants under the scheme to fund definitive trials (this call has now closed).

The size of the grant may vary but a general guideline would be up to £200,000 Full Economic Cost (fEC). However, grants exceeding this value will still be considered if the costs are fully justified. Applicants wishing to exceed this should contact the office to discuss prior to applying; not doing so may lead to your application being rejected.

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 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.

Development grants undergo single stage review by an expert panel. Funding decisions are expected in December 2020.

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.

You must apply through the Joint Electronic Submission system (Je-S).

When applying select:

  • council: MRC
  • document type: Standard Proposal
  • scheme: MRC Jointly Funded Initiatives Full
  • call/type/mode: MRC NIHR DfID Wellcome Global Health Trials Call 11 – Development Feb 2021

Visit funding web page
(https://www.ukri.org/opportunity/joint-global-health-trials/)