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Global health trials programme

The information provided below applies to you only if you wish to submit a proposal for a large scale, late phase, trial in global health research.

Otherwise please read the guidance on the MRC’s new role in trials

Global health trials

The MRC continues to accept proposals for large scale trials in global health research which are relevant to MRC’s published strategic aims. The final decision to support a global health trial is taken by MRC Strategy Board. Proposals will be considered by using the process and criteria outlined below.

In addition to funding global health trials through this response-mode programme, MRC participates in a joint global health trials scheme with the UK Department for International Development and the Wellcome Trust. The joint scheme funds late phase trials of health interventions in low income settings, with a focus on trials which incorporate research that will lead to effective implementation of results. The scheme is now closed for the 11/12 annual call. A new call will be announced later this year, details are available here in our call for proposals section of the website.

If you have a query about whether you should submit your proposal to the MRC global health trials programme or to the joint global health trials scheme, please email jointglobalhealthtrials@headoffice.mrc.ac.uk for advice.

What is a trial grant?

The MRC funding for trial grants aims to provide support for clinical trials to provide high quality evidence on the comparative efficacy and effectiveness of interventions in medicine and health services.

The focus of the MRC’s support is primarily on trials that:

Break new ground in terms of research questions or methodologies;
Add significantly to our understanding of biological or behavioural mechanisms and processes in human health and health care.

Our support is not focussed on:

Confirmatory studies or trials of incremental modifications and refinements to existing health technologies;

Trials in global health are those whose focus is on evidence of efficacy and effectiveness of interventions related to a major health need predominant in developing countries (i.e. combating tropical disease for example, malaria). For further advice please contact Dr Morven Roberts.

Key features

An underlying principle of our support is that the proposed trials should, as far as is practicable, be fully developed and costed before they are allowed to start; also that progress should be monitored throughout the lifetime of the trial.

Where a recent review does not already exist, applicants are encouraged to conduct a systematic review of the available evidence, and preferably a pilot or feasibility study, before applying for a grant for a large scale, late phase, definitive trial.

The MRC will consider funding for a pilot or feasibility stage but only in the context of a well developed proposal for a definitive study. Applicants must be able to demonstrate a clear commitment to carrying out the main trial if the pilot proves successful.

If you are in doubt please contact Dr Morven Roberts.

Who can apply?

Any UK-based researcher who can demonstrate that they will direct the proposed research and be actively engaged in carrying it through.

The minimum academic qualification required is a graduate degree, although usually a PhD is required. Less experienced researchers should apply in collaboration with more senior colleagues. Applicant(s) must demonstrate that they will direct the proposed research and be actively engaged in the work. Evidence of strong management and clinical trials expertise will be anticipated. It is anticipated that the majority of global health trials will involve strong collaboration with investigators in the developing countries concerned.

Financial support

Under the trials grant scheme you may request support for:

All research costs that are directly attributable to the trial. For example, scientific, technical and administrative staff including statisticians, research nurses, trial managers etc; consumables; major items of equipment and travel.
The cost of holding trial steering, data monitoring and ethics committees.
Request for training and support for a trial manager.

The MRC will usually fund on the basis of up to 80 per cent of the full economic cost of your research to your institution, so your proposal must show 100 per cent of the full economic costing throughout.

There may be a case for costs incurred by institutions in developing countries to be supported at a 100 per cent under exceptions. These costs need to be approved in advance.

It is unlikely that global health trials will incur NHS costs however please refer to the trial grant annex to the applicant’s handbook and NHS guidance for researchers for non-commercial externally funded R&D for further information.

Regulation, governance and liability may vary amongst different countries, chief investigators and proposed sponsors should ensure 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 is responsible for ensuring adequate arrangements are in place at each site.

Trial grants may only be extended in exceptional circumstances.

How to apply? Submitting a proposal

Please contact Dr Morven Roberts in the first instance to discuss your proposal.

Consideration of trial grant applications is a two stage process.

You must submit an outline application in the first instance, which will be considered by MRC Global Health Group. An outline can be submitted at any time, but should be constructed using the template that is provided and to the date agreed with Dr Morven Roberts. Outlines are submitted through the Joint Electronic submission System Je-S system.

Invited full trial grant applications will be considered by MRC Global Health Group, with additional experts necessary to fully assess global health trial grant proposals who will make recommendations to Strategy Board who will take a final funding decision.

First stage; Outline Application

You must submit an outline of your proposal in the first instance.

Contact morven.roberts@headoffice.mrc.ac.uk; to agree a date for submission
Construct the EoI using the dedicated template provided
Read the MRC applicant’s handbook which will guide you through general aspects of preparing a proposal, including eligibility, case for support, costing your proposal and any ethical and regulatory requirements that may apply to the research;
Please ensure that you also look at the terms and conditions governing MRC grants;
Submit the completed outline and other requested documentation through the Joint Electronic submission System Je-S system.
For all MRC global health trial grants please use Dr Morven Roberts as your contact.

Assessment criteria for EoI will be based on

Importance of the question being addressed;
Potential impact on clinical practice or health care in developing countries
Feasibility (in delivering outcome ie appropriate management, partnering);
Justification for resources.

Invited full proposal

Following consideration of your outline application you will receive notification of whether you have been invited to submit a full proposal. You will agree a date for submission of the full application which would normally be within six months of the invitation.

Submitting an invited full proposal

Only applicants who have been invited to submit a full application should apply. Applicants will receive the full trial template and guidance when invited to submit.

Read the MRC applicant’s handbook, and the additional requirements for trial grant applicants listed in the trial grant annex.
Please ensure that you also look at the terms and conditions governing MRC grants.

Your completed full proposal must be submitted through the Joint Electronic submission System Je-S system . This is done by your research institution’s administrative department, after they have completed their section of your application.
To ensure that your application reaches us in time, please give your administrative department at least two weeks’ notice of your application and the deadline date.

Deadlines

Outline Application

An outline can currently be submitted at any time. Please contact Dr Morven Roberts to discuss submission of the outline and who will send you the template and agree with you a specific date.

Invited full trial grant applications will be given a specific date for submission. Submit your global health trial grant proposal through the Je-S system by 4pm on the deadline date.

The assessment procedure

Full proposals are peer reviewed by independent scientific experts from the UK and overseas.

Criteria for assessment of full trial grant applications are explained in the trial grant annex.

Please note that applicants must not lobby MRC staff, referees or members of peer review panels and boards, nor submit additional information in support of an application after the original submission date. To do so may result in the application being withdrawn by the MRC. More about the assessment procedure.