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Joint Global Health Trials scheme – launch of sixth call for proposals -pg2

Funds for NGOs Last date 10 Sep 2015

Activities: Health/Nutrition,Others

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. http://www.mrc.ac.uk/research/research-policy-ethics/clinical-research-governance/clinical-trials-regulations/

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-classificationsopens in new window

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.
 
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