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Diagnostic tools for poverty-related diseases

Status: Active
Type of action: Research and Innovation Action (RIA)
Call budget: €18 million
Funding level: 100% of eligible costs
Stage 1 Open date: 6 June 2018, 00:00
Stage 1 Close date: 11 October 2018, 17:00
Stage 2 Open date: 21 December 2018, 00:00
Stage 2 Close date: 21 March 2019, 17:00
Go to EDCTPgrants

Expected number of grants: 6-12
Call identifier: RIA2018D

Description

Background
Disease diagnosis in sub-Saharan Africa is highly challenging, as the population has limited access to health care systems. Early and rapid diagnosis of poverty-related diseases (PRDs) offers the best opportunity for patients to receive timely and appropriate treatment, but adequate diagnostic tools are not readily available because of a lack of drive to develop and deploy them in disease-endemic countries. In addition, co-infections with several pathogens are frequent in many populations and represent further challenges in the diagnosis of many PRDs. There is therefore a clear need for the development and uptake of rapid, accurate, cost-effective, scalable and field-friendly diagnostic tools.

Scope
Projects should focus on validation of the clinical performance and/or implementation of new or improved diagnostic tools and technologies for the detection of any of the PRDs*, including co-infections. The proposed tools and technologies should improve the performance of diagnosis, prediction, monitoring, intervention or assessment of therapeutic response, with a significant impact on clinical decision and health outcomes. Proposals should focus on late stage development (e.g. evaluation and/or demonstration phase trials) or implementation studies in sub-Saharan Africa. Diagnostic algorithms to detect multiple infections are also welcome. Additionally, proposals should provide detailed plans for the uptake of the diagnostic tools and technologies upon successful completion of the project, including engagement with WHO or other relevant policy makers as well as plans for product registration (i.e. CE mark).

Proposals focused entirely on early-stage, laboratory-based studies using biobanked samples are outside the scope of this call. Priority will be given to point-of-care diagnostics for use in resource-limited settings.

EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 1 and 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

EDCTP considers that proposals of between 24 and 48 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for activities of a different duration.

Expected impact
Projects funded under this Call for Proposals should:

  • contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
  • lead to improvements in patient care through early detection and treatment of disease and/or enhanced monitoring and tracking of disease progression and therapeutic response
  • contribute towards the implementation of innovative, rapid and simple diagnostics that can be deployed at low cost in health systems in resource-poor settings
  • contribute to reduce infections by key antimicrobial resistant microorganisms in humans as recommended by the Global Action Plan Against Antimicrobial Resistance (PDF) and by the European Action Plan Against Antimicrobial Resistance (AMR) 2017
  • be in line with EDCTP2’s strategic research agenda (PDF) to be considered as having a higher impact.

 

Eligibility
A proposal/application will only be considered eligible if:

  1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
  2. it complies with the eligibility conditions set out below, depending on the type of action:
    • Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities shall be established in two different Participating States (European Partner States) and one of the legal entities must be established in a sub-Saharan African country. All three legal entities shall be independent of each other.
    • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

 

Note

* In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV/AIDS, malaria, tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; foodborne trematodiases; lymphatic filariasis; mycetoma; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as Ebola or yellow fever.

Procedure and application process

Two-stage application procedure. For the first stage, a letter of intent must be submitted by the first deadline. Successful applicants in the first stage will be invited to submit a full proposal for the second stage.

  • Proposals for Stage 1 must be submitted by 11 October 2018 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 1 are expected to be made available by 21 December 2018.
  • Proposals for Stage 2 must be submitted by 21 March 2019 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 2 are expected to be made available by 25 July 2019.

 

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence
The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the work plan:

  • Fit with the scope and objectives of the EDCTP2 Programme, the EDCTP strategic research agenda and the call topic description
  • Importance, relevance/pertinence and clarity of the objectives
  • Soundness of the concept and credibility of the proposed approach/methodology
  • Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) or research study now
  • Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial
  • Extent that the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally
  • Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge.

 

2. Impact
The following aspects will be taken into account:

  • Call specific aspects as listed under ‘expected impact’ in each individual call
  • The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic
  • Likelihood to result in major advances in the field
  • Advancing the clinical development of new and improved products.
  • Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results
  • Contribution to improved disease management and prevention through changes in policy, with the ultimate goal of improving public health
  • Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials
  • Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data.

 

3. Quality and efficiency of the implementation
The following aspects will be taken into account:

  • Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables
  • Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met
  • Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise
  • Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role
  • Feasibility and appropriateness of the methods and project management to achieve the objectives within the time frame of the grant
  • Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues
  • Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s)
  • Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP)
  • Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial
  • Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).

 

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions
The call budget is €18 million.

The EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 1 and 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. The funding level is 100% of eligible costs.

Grant agreement
EDCTP2 multi-beneficiary grant agreement.

Application process

  • The application must be submitted online via EDCTPgrants
  • Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible.

Documents and other information

Documents

 

More information