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Joint Global Health Trials (JGHT) – Call 10 Trial Development

 

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The UK Department for International Development (DFID), the National Institute for Health Research (NIHR), the MRC and Wellcome are pleased to announce the launch of the 10th call for proposals under this initiative to fund global health trials.

Call 10 specifically invites applications for definitive RCTs that provide generalisable data, beyond a single country. The evidence generated should be robust and relevant to international and regional policy makers and directly answer questions to change policy and guidance.

This call is open to and particularly encourages applicants to apply from eligible research institutions based in low and middle income countries as well as the UK.

On this page:

Background

DFID, NIHR, MRC and Wellcome each have a strong history of supporting research that aims to improve health in low and middle income countries (LMIC). The four 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 to improve health in LMIC settings. 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 fund up to £20 million for the 10th call to be launched under the joint global health trials partnership.

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Objectives and remit

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. The scheme is focused on late-stage clinical and health intervention trials evaluating efficacy and effectiveness.

Proposal types

  • Global health trial research grants
  • Trial development grants

Priorities for this call

The scheme will give priority to proposals for definitive trials that are likely to produce implementable and generalisable results to change policy and practice. Trials should address the major causes of mortality or morbidity in low and middle income countries, particularly those that affect the most vulnerable populations.  We are open to funding a smaller number of more ambitious trials than in previous years.

Applications must engage with the potential users of research for future implementation and impact for policy. 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.

Remit

Methodology

The joint global health trials scheme funds randomised controlled trials (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 may consider Phase IIb trials of major relevance to the objectives of the call, but please contact the office to discuss this beforehand.

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.

Intervention type

Although the breadth of the scheme is deliberately wide, we particularly welcome proposals for research addressing to 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.

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 DAC List of ODA Recipients. The scheme encourages Principal Investigators to apply from these countries.

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.

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 comment on the potential impact and broader applicability of the intervention beyond academic contributions.
  • 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.
  • It is important that the results of research funded under this scheme have the potential to be implemented at scale. We therefore encourage applicants to include, where relevant, health systems, economics and implementation research in their proposals to provide lessons relevant to 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 the development grant strand of the scheme.

Funding for development grant proposals

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.

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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 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.

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How to apply

Applications will be submitted to and processed by MRC on behalf of the four partner agencies.

There are two application types:

  • Global health trial research grants (two stage application process, decisions for invitation for full stage in December 2019, funding decision in June 2020). Please note, the deadline for outline applications has now passed and the MRC will not accept any further applications of this kind.
  • Trial development grants (one stage application process, funding decision in June 2020).

Please see the Guidance documents for further information on applying through either route.

The MRC must receive your trial development proposal by 16:00 Greenwich Mean Time on Wednesday 2 February 2020.

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Funding available

A total of up to £20 million is available for this call. The funders welcome trial proposals costed appropriately to provide definitive results. Around £1 million of the total amount 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.

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.

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Eligibility

Principal Investigators

This scheme is open to Principal Investigators who are employed by eligible institutions based in LMICs 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). 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 applications to be predominantly based in LMIC.  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 country outside the UK cannot be a Principal Investigator on a proposal but can be a Co- investigator.

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.

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Evaluation process

Applications will be considered by an expert panel convened specifically for this scheme jointly agreed by MRC, DFID, Wellcome and NIHR. 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 outline proposal as there will not be an opportunity to add additional information after submission.

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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.

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Dates

The joint funders of this scheme consider applications once a year:

Global health trial research grants

  • Outline proposal deadline – 17 October 2019 (16:00 BST)
  • Decision about outline proposals – December 2019
  • Invited full application deadline- February 2020
  • Final decision- July 2020

Trial development grants

  • Trial development application deadline – 5 February 2020
  • Final decision- July 2020

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Contacts and guidance

All enquiries should be directed in the first instance to the MRC: JGHT@mrc.ukri.org

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